[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohn-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohn-disease":20},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,162,0,25,[9,49,85,106,132,155,170,191,212,235,257,275,295,315,333,358,387,410,432,457,481,507,529,555,580],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":46,"locationsCount":4},"100374756","expanded-access-to-upadacitinib-100374756",false,"NCT04159597","Expanded Access to Upadacitinib","Exclusion Criteria:\n\n* There are other suitable treatment options.\n* The participant qualifies for ongoing clinical trials.","ALL","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[20,21,22,23,24,25,26,27,28,29,30,31,32,33],"Crohn Disease","Ulcerative Colitis","Idiopathic Arthritis (Including sJIA, pJIA, or JPsA)","Atopic Dermatitis","Rheumatoid Arthritis","Psoriatic Arthritis","Axial Spondyloarthritis","Non-radiographic Axial","Spondyloarthritis","Giant Cell Arteritis","Systemic Lupus Erythematosus","Alopecia Areata","Non Segmental Vitiligo","Hidradenitis Suppurativa",[35,36,37,38,39,40],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE","2026-08-18",{"date":44,"type":45},"2026-08-20","ACTUAL",{"name":47,"class":48},"AbbVie","INDUSTRY",{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100652680","intestinal-ultrasound-guided-management-in-inflammatory-bowel-disease-100652680","NCT07775352","Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease","A Randomized Controlled Trial Comparing Standard of Care With and Without Intestinal Ultrasound Guidance in Patients With Inflammatory Bowel Diseases","Inclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease for more than 2 months\n* Age 18 years or older\n* Undergoing endoscopy at enrollment for assessment of disease severity\n\nExclusion Criteria:\n\n* Pregnancy\n* Unstable underlying medical conditions\n* Inflammatory bowel disease limited to the distal rectum (within 10 cm of the anal verge) or perianal disease only\n* Biologic failure","18 Years",{"count":58,"type":59},137,"ESTIMATED","INTERVENTIONAL",[62],"NA","This randomized controlled trial evaluates whether adding point-of-care intestinal ultrasound (IUS) to standard of care changes clinical management in patients with inflammatory bowel disease (IBD). Adult patients with Crohn's disease or ulcerative colitis undergoing colonoscopy for disease assessment are randomized 1:1 to standard of care plus IUS at every visit, or standard of care alone, and followed for 48 weeks. The primary outcome is the proportion of patients with a change in treatment.",[65,20,66],"Inflammatory Bowel Diseases","Colitis, Ulcerative",[68,69,70,71,72,73],"intestinal ultrasound","IBD","point-of-care ultrasound","treat-to-target","bowel wall thickness","IBUS-SAS","RECRUITING","2026-08-16",{"date":44,"type":45},{"date":78,"type":45},"2026-03-25",{"date":80,"type":59},"2028-03",{"name":82,"class":83},"Mahidol University","OTHER",1,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":84},"100652171","lesion-size-measurement-during-gastrointestinal-endoscopies-100652171","NCT07770425","Lesion Size Measurement During Gastrointestinal Endoscopies","AccuMeasure","Inclusion Criteria:\n\n* Adult patients (18 years and older)\n* Patients undergoing gastrointestinal endoscopy procedures\n\nExclusion Criteria:\n\n* Minors: Patients under 18 years of age.\n* Patients who do not provide informed consent.\n* Patients undergoing endoscopy on an emergency basis (defined as urgent diagnostic or therapeutic endoscopy performed on the gastrointestinal (GI) tract to address potentially life-threatening conditions or severe symptoms that require immediate medical attention).\n* An American Society of Anesthesiologists (ASA) physical status classification greater than 3.",{"count":93,"type":59},3000,"OBSERVATIONAL","The goal of this prospective observational study is to assess the accuracy and reliability of laser readings obtained through AccuMeasure, in comparison to other measurements performed by gastroenterologists. AccuMeasure is a novel technology, that has emerged as a promising tool for measuring polyps and lesions during colonoscopies. The system employs laser-based measurements, enabling precise determination of lesion size, depth, and extent. The main hypotheses this study aims to evaluate are:\n\n* AccuMeasure technology, with its precise laser measurements, will demonstrate superior accuracy and reliability in assessing lesion size of pathologies encountered during endoscopies, when compared to other endoscopic scoring methods.\n* AccuMeasure measurements will show strong construct validity by correlating significantly with endoscopic subscores, symptomatic remission (CD PRO2 \\\u003C8, partial mayo score), and fecal calprotectin values.",[97,20],"Polyp of Colon","2026-08-13",{"date":42,"type":45},{"date":101,"type":45},"2025-05-09",{"date":103,"type":59},"2027-11",{"name":105,"class":83},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":16,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":119,"studyType":94,"phases":4,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100329603","pibd-setquality-the-inception-cohort-and-safety-registry-100329603","NCT03571373","PIBD-SETQuality: the Inception Cohort and Safety Registry","Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry","PIBD-SETQ","Inclusion Criteria Inception cohort:\n\nNewly diagnosed patient, \\\u003C18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:\n\n* Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)\n* Diagnosis has been made or is confirmed within 2 months of inclusion\n* Data on all diagnostic procedures are available for inclusion in the database\n* Informed consent of patient (if indicated) and parents has been obtained\n* Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet\n\nInclusion Criteria Safety Registry:\n\nAny child with IBD \\\u003C19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required.\n\nExclusion Criteria Inception cohort:\n\n* Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)\n* Informed consent of patient or parents has not been obtained when required\n* Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)\n\nExclusion Criteria Safety registry: none.",true,"0 Years","19 Years",{"count":118,"type":59},1500,"20 Years","The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.",[65,20,21],"2026-08-07",{"date":124,"type":45},"2026-08-11",{"date":126,"type":45},"2017-01-03",{"date":128,"type":59},"2030-12-31",{"name":130,"class":83},"Erasmus Medical Center",2,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":60,"phases":142,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":154},"100630086","phase-2-a-study-of-ly4395089-and-mirikizumab-ly3074828-given-together-and-mirikizumab-alone-in-adults-with-crohns-disease-100630086","NCT07483099","A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease","A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089\u002FMirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease","Inclusion Criteria:\n\nParticipants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:\n\n* Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1\u002Fglucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1\u002Fglucagon (Gcg) RAs, GLP-1\u002FGIP\u002FGcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:\n\n* Must not have a hepatic disease\n* Must not have a history of any other bone disease that affects bone metabolism\n* Must not have had any of the following within the past 180 days before screening:\n\n  * acute myocardial infarction\n  * cerebrovascular incident\n  * hospitalization for unstable angina\n  * hospitalization due to congestive heart failure, or\n  * coronary revascularization\n* Must not have received or will need any other prohibited medications as specified in the protocol","80 Years",{"count":141,"type":59},60,[143],"PHASE2","The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.",[20],"2026-08-05",{"date":148,"type":45},"2026-08-06",{"date":150,"type":45},"2026-05-04",{"date":80,"type":59},{"name":153,"class":48},"Eli Lilly and Company",70,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":139,"enrollmentInfo":162,"targetDuration":4,"studyType":60,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":169,"locationsCount":154},"100630084","phase-2-a-master-protocol-iibd-a-study-of-multiple-drugs-in-adults-with-ulcerative-colitis-or-crohns-disease-100630084","NCT07483073","A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.\n* For UC:\n\n  * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.\n* For CD:\n\n  * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization\n* Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD\n* Have screening laboratory test results within the protocol specified parameters.\n\nExclusion Criteria:\n\n* Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis\n\n  * For UC - must not have a current diagnosis of CD\n  * For CD - must not have a current diagnosis of UC\n* Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol\n* Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome\n* Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data\n* Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action\n* Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment\n* Must not have received or will need any prohibited medications for UC or CD as specified in the protocol",{"count":141,"type":59},[143],"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.",[66,20],{"date":148,"type":45},{"date":150,"type":45},{"date":80,"type":59},{"name":153,"class":48},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":60,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100456944","treat-to-target-of-endoscopic-remission-in-patients-with-ibd-in-symptomatic-remission-100456944","NCT05230173","Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission","QUOTIENT","INCLUSION CRITERIA:\n\nParticipants must meet all of the following criteria for enrolment into the study.\n\n1. Male or nonpregnant, nonlactating females, ≥ 18 years of age.\n2. An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.\n3. Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., TNFα antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial.\n4. Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy\u002Fradiology. No treatment escalation of TIM or addition of IMM, corticosteroid, or mesalamines after the qualifying endoscopy\u002Fradiology procedure up to randomization is permitted. Dose de-escalation after qualifying procedure is permissible at the discretion of the treating provider.\n5. In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experiencing no other IBD-related symptoms in the opinion of the treating provider. Includes patients who may be in medically induced remission (on index TIM); or surgically induced remission with post-op initiation of index TIM for prophylaxis and colonoscopy\u002Fimaging performed at least 3 months after initiation\u002Foptimization of TIM showing moderate-severe bowel inflammation. Validated PROs are defined as:\n\n   1. CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or\n   2. UC: PRO2, with absence of rectal bleeding (rectal bleeding score = 0) and with stool frequency score ≤1.\n6. Evidence of moderate to severe bowel inflammation on local reading of colonoscopy, flexible sigmoidoscopy, balloon-assisted enteroscopy, capsule endoscopy or MR, CT enterography, or intestinal ultrasound, performed within 6 months prior to screening, defined at the investigator's discretion or as follows:\n\n   1. CD: Colonoscopy showing moderately to severely active inflammation based on 1 of the following variables\u002Fscores:\n\n      * Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 or score ≥4 for those with isolated ileal disease, or\n      * Presence of mucosal ulcers \\>5 mm in size if SES-CD has not been recorded, or\n      * Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) score ≥2, or\n      * Rutgeerts score i2b or higher for patients in surgically induced remission with post-operative endoscopic recurrence \\[Note, either SES-CD or Rutgeerts score can be used for participants with post-operative recurrence\\]; or\n   2. CD: MRE or CTE showing moderately to severely active inflammation based on 1 of the following variables:\n\n      * Increased bowel wall thickness, or\n      * Mural hyperenhancement, or\n      * Peri-enteric fat stranding, or\n      * Radiographic features of ulceration, or\n      * Intramural T2 signal on fat suppressed images; or\n   3. CD: Capsule endoscopy showing moderately to severely active small bowel disease based on Lewis score \\>790 (in case the disease is not accessible via endoscopy), or per local endoscopist if Lewis score is not reported; or\n   4. CD: Gastrointestinal ultrasound showing at least 1 of the following variables:\n\n      * Increased bowel wall thickness \\>5 mm, or\n      * Color doppler score \\>5\u002Fcm2, or\n      * Bowel stenosis, or\n      * Bowel stratification, or\n      * Fatty wrapping; or\n   5. UC: modified MES score of 2 to 3, or documentation of any endoscopic feature that would define an MES of 2 to 3 (e.g., friability, ulceration, spontaneous bleeding, complete loss of vascular pattern), if an MES has not been recorded.\n7. Eligible to receive at least 1 alternative TIM (excluding their index TIM) for the treatment of their disease per approved drug label, based on clinical and reimbursement guidelines.\n8. Able to participate fully in all aspects of this clinical trial.\n9. Informed consent must be obtained and documented.\n\nEXCLUSION CRITERIA:\n\nParticipants who exhibit any of the following conditions are to be excluded from the study.\n\n1. Presence of ostomy or ileoanal pouches.\n2. Serious underlying disease other than UC or CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.\n3. History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.\n4. Prior enrolment in the current study.\n5. Mild endoscopic disease activity, where treating providers would not consider switching TIM.",{"count":178,"type":59},216,[62],"The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis \\[UC\\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.",[21,20],"2026-08-04",{"date":122,"type":45},{"date":185,"type":45},"2022-10-05",{"date":187,"type":59},"2029-02-01",{"name":189,"class":83},"Mayo Clinic",24,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100650419","a-study-of-continued-use-of-guselkumab-in-participants-with-crohns-disease-and-ulcerative-colitis-in-real-world-setting-100650419","NCT07746765","A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting","Real-world Observational Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis","GusTaCon","Inclusion criteria:\n\n* Participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug\n* Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records\n* Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":200,"type":59},35,"The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.",[20,66],"NOT_YET_RECRUITING","2026-07-31",{"date":146,"type":45},{"date":207,"type":59},"2026-08-03",{"date":209,"type":59},"2029-08-03",{"name":211,"class":48},"Janssen Sciences Ireland UC",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":60,"phases":222,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100643826","phase-3-a-study-of-jnj-78934804-in-participants-with-moderately-to-severely-active-crohns-disease-100643826","NCT07577843","A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","DUET ENCORE-CD","Inclusion criteria:\n\n* Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \\>= 220 but less than or equal to (\\\u003C=) 450 and either: a. Mean daily stool frequency (SF) count \\>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \\>= 2.0, based on the unweighted CDAI component of abdominal pain (AP)\n* Have moderately to severely active ileal and\u002For colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria\n* Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies\n\nExclusion criteria:\n\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC\n* Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study\n* Presence of draining (that is, functioning) stoma or ostomy\n* Has a history of short bowel syndrome, is missing greater than (\\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention\n* Currently has or is suspected of having an abscess",{"count":221,"type":59},460,[223],"PHASE3","The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \\[worsens with time\\] and life-threatening disease of the intestine).",[20],"2026-07-30",{"date":204,"type":45},{"date":229,"type":45},"2026-05-22",{"date":231,"type":59},"2030-07-12",{"name":233,"class":48},"Janssen Research & Development, LLC",55,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":242,"minAge":56,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":60,"phases":245,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":84},"100642162","phase-4-a-study-to-assess-concentration-of-tremfya-in-breast-milk-of-lactating-women-who-are-receiving-tremfya-therapeutically-100642162","NCT07654751","A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","CNTO1959ISD4001: A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","Inclusion criteria:\n\n* Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \\[PsA\\], UC and CD) as confirmed by medical records\n* Be medically stable on the basis of medical history review performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator\n* Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1\n* Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study\n* Must be at least 5 weeks postpartum on Day 1\n* Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula\u002Fday) when enrolled in the study\n* Must plan to continue breastfeeding throughout the duration of the study\n\nExclusion criteria\n\n* Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments\n* Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening\n* Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study\n* Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \\[COVID-19\\]) by local health authorities are allowed\n* Has a positive urine pregnancy test on Day 1","FEMALE",{"count":244,"type":59},10,[246],"PHASE4","The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.",[249,66,20,250],"Psoriasis","Arthritis, Psoriatic",{"date":204,"type":45},{"date":253,"type":59},"2026-10-01",{"date":255,"type":59},"2027-08-31",{"name":233,"class":48},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":84},"100638573","a-study-of-guselkumab-in-participants-with-crohns-disease-and-ulcerative-colitis-100638573","NCT07606339","A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis","Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis","G-FORCE","Inclusion criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration\n* Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records\n* Must sign a participation agreement\u002Finformed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":200,"type":59},"The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.",[20,66],{"date":204,"type":45},{"date":270,"type":45},"2026-06-10",{"date":272,"type":59},"2029-06-15",{"name":274,"class":48},"Janssen-Cilag Pharma GmbH",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":60,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":294},"100631327","phase-3-a-study-of-guselkumab-versus-risankizumab-in-participants-with-moderately-to-severely-active-crohns-disease-100631327","NCT07499232","A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease","A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease","CHARGE","Inclusion criteria:\n\n* Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and\u002For endoscopy\n* Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220 but less than or equal to (\\\u003C=) 450\n* Baseline endoscopic evidence of active ileal and\u002For colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \\>= 4 (for participants with isolated ileal disease) or \\>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:\n\n  1. a minimum score of 1 for the component of \"size of ulcers\" AND\n  2. a minimum score of 1 for the component of \"ulcerated surface\"\n* In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study\n* Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol\n\nExclusion criteria\n\n* Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab\n* Currently has or is suspected to have an abscess\n* Has an active fistula during screening or at Week 0 with an anticipated need for surgery\n* Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention\n* Currently has a malignancy or has a history of malignancy within 5 years before screening",{"count":284,"type":59},530,[223],"The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).",[20],{"date":204,"type":45},{"date":290,"type":45},"2026-04-21",{"date":292,"type":59},"2030-12-11",{"name":233,"class":48},144,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":60,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100608066","phase-2-a-study-of-icotrokinra-in-participants-with-moderately-to-severely-active-crohns-disease-100608066","NCT07196722","A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease","A Phase 2b\u002F3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease","ICONIC-CD","Inclusion Criteria:\n\n* Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \\>=220 but \\\u003C=450 and either mean daily SF count \\>=4, or mean daily AP score \\>=2\n* Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and\u002For colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \\>= 6 for participants with colonic or ileocolonic disease, and SES-CD \\>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments\n* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests\n* Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \\[ADT\\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and\u002For advanced oral agents for the treatment of CD- (ADT-inadequate responder \\[IR\\]) as defined in the protocol\n\nExclusion criteria:\n\n* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and\u002For could impair the use of instruments (such as CDAI) to assess response to study intervention\n* Presence of a stoma or ostomy\n* Participants with presence of active fistulas may be included if there is no surgery needed\n* Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline\n* Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization",{"count":304,"type":59},1092,[143,223],"The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).",[20],{"date":204,"type":45},{"date":310,"type":45},"2025-10-03",{"date":312,"type":59},"2032-10-06",{"name":233,"class":48},368,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":84},"100391063","a-study-to-assess-the-long-term-safety-of-ustekinumab-versus-other-biologics-in-patients-with-crohns-disease-and-ulcerative-colitis-100391063","NCT04372108","A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis","RRA-18896: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database","Inclusion Criteria:\n\n* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period\n* Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs\n\nExclusion Criteria:\n\n* Participants below 18 years of age on the exposure index date\n* Participants who do not meet the definition for CD or UC prior to or on the exposure index date\n* Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \\[NMSC\\]) at any time prior to or on the exposure index date\n* Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date\n* In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded",{"count":323,"type":59},1536,"The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).",[20,66],{"date":204,"type":45},{"date":328,"type":45},"2021-06-24",{"date":330,"type":59},"2030-08-30",{"name":332,"class":48},"Janssen Scientific Affairs, LLC",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":16,"minAge":339,"maxAge":139,"enrollmentInfo":340,"targetDuration":4,"studyType":60,"phases":342,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100382761","phase-1-low-dose-il-2-for-the-treatment-of-crohns-disease-100382761","NCT04263831","Low Dose IL-2 for the Treatment of Crohn's Disease","Inclusion Criteria:\n\n1. Age 12-80 years. Maximum age limit for subjects recruited at BCH will be 30 years.\n2. A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria.\n\n   a. A subset of patients with Ileostomies or colostomies will be permitted.\n3. Adult subjects with moderate-to-severe CD (CDAI score 220-450)\n\n   a. a modified CDAI will be used to assess patients with ileostomies\u002Fcolostomies. Number of liquid stools per day will be substituted for number of bag empties per day.\n4. Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy\n\n   1. Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease\n   2. patients with ileostomies will be assessed as patients with isolated ileal disease via SES-CD.\n5. Failure to tolerate or failure to respond to at least one conventional therapy with the intention of inducing or maintaining remission (including but not limited to oral corticosteroids, oral 5-aminosalicylates, azathioprine and\u002For 6-mercaptopurine, TNF alpha antagonist, anti-integrins, ustekinumab). Corticosteroid dependency (inability to taper oral corticosteroids without a recurrence of disease activity) is also included in this category.\n6. Stable doses of concomitant medications, as defined in Section 5\n7. A negative pregnancy test within 2 weeks prior to anticipated commencement of the study drug, in female subjects of child-bearing age. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.\n8. The ability of adult participants who are able to make their own healthcare decisions to provide informed consent or the ability of a legal guardian to provide consent if the participant is a child (less than 18 years of age) or has mild intellectual disability and cannot consent for him or herself. In the event that a legal guardian provides consent, the study participant must be able to demonstrate an understanding of the study at his or her comprehension level and must have the ability to give verbal assent. If the legal guardian is court appointed, then the legal guardian must be able to provide documentation of court appointed guardianship.\n\nExclusion Criteria:\n\n1. A diagnosis of ulcerative colitis or indeterminate colitis.\n2. Requirement for immediate surgical, endoscopic or radiological intervention for perforation, sepsis, or intra-abdominal or perianal abscess.\n3. History of colorectal cancer or dysplasia.\n4. Positive stool test for Clostridium difficile via GDH\u002FEIA two step testing method. PCR only testing will not be accepted. If patient is GDH positive and EIA negative, enrollment will be permitted.\n5. Current medically significant infection.\n6. Significant laboratory abnormalities;\n\n   1. Hb \\\u003C 7.0 g\u002FdL, WBC \\\u003C 2.5 x 103\u002Fmm3, Plt \\\u003C 50 x 103\u002Fmm3.\n   2. Creatinine ≥ 2x institutional ULN.\n   3. Total bilirubin \\> 2.0 mg\u002FdL, ALT \\> 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.\n   4. Abnormal thyroid function tests.\n7. Positive serology for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).\n8. Positive screening test for tuberculosis (TB).\n9. Treatment with any biologic medication within 4 weeks of first study drug dose (baseline) (see below section on washouts)\n10. Received another IND within 5 half-lives of that agent baseline.\n11. Malignancy within the last 5 years, excluding non-melanoma skin cancer.\n12. Allergy to any component of the study drug.\n13. Pregnant or lactating women.\n14. Inability to comply with the study protocol or inability of the subject or the subject's legal guardian to provide informed consent.\n15. Prior exposure to IL-2.\n16. Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).","12 Years",{"count":341,"type":59},30,[343,143],"PHASE1","The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe crohn's disease.",[20],[347,348,349],"Inflammatory bowel disease","Interleukin 2","Regulatory T Cells",{"date":207,"type":45},{"date":352,"type":45},"2021-03-11",{"date":354,"type":59},"2027-12-30",{"name":356,"class":83},"Boston Children's Hospital",3,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":60,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":386},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":366,"type":59},300,[343],"This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[370,20,371,372,373,374,375,249,25,24,376,30,377,21],"Autoimmune Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Sjogren Syndrome","Systemic Scleroderma",{"date":204,"type":45},{"date":380,"type":45},"2019-07-16",{"date":382,"type":59},"2028-03-30",{"name":384,"class":385},"National Cancer Institute (NCI)","NIH",52,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":60,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100437219","study-of-the-added-value-of-a-transmural-evaluation-in-patients-with-crohns-disease-under-biotherapy-with-close-fecal-calprotectin-follow-up-100437219","NCT04973423","STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP","Deeper","Inclusion Criteria:\n\n* Adult Crohn's disease (age ≥ 18 years)\n* Symptomatic with Crohn's disease activity index (CDAI)\\> 150\n* Presence of objective signs of inflammatory activity (fecal calprotectin\\> 250 AND sign of MRI activity)\n* Requiring treatment with biotherapy according to the investigator\n* Able to give informed consent to participate in research\n* Affiliation to a Social Security scheme.\n\nExclusion Criteria:\n\n* Severe obstructive symptoms\n* Uncontrolled intra-abdominal abscess\n* Isolated anoperineal lesions\n* Prevention of postoperative endoscopic recurrence\n* Temporary or definitive ostomy\n* Total colectomy\n* Contraindication to MRI\n* Pregnant or breastfeeding women\n* Protected adults (curatorship, guardianship, saving justice)\n* Refusal of participation",{"count":395,"type":59},180,[62],"Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients. Due to its transmural nature (involvement of the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula) which requires intestinal resection in approximately half of patients during their follow-up. The long-term goal for patients is to maintain a normal life, that is, without symptoms and without intestinal destruction. For this, the short and medium term therapeutic objectives have evolved in recent years. Clinical remission is not a sufficient goal since it has failed to alter the natural history of the disease. The current objective to be achieved is the combination of clinical remission and endoscopic mucosal healing since it is associated with a reduced risk of progression (reappearance of symptoms, hospitalization, intestinal resection). Fecal calprotectin, better accepted than colonoscopy, is a non-invasive biomarker of endoscopic inflammatory activity in CD. The CALM study recently showed that close follow-up with clinical and biological evaluation (assays of CRP and fecal calprotectin), called \"tight control\", associated with therapeutic intensification in the absence of clinical or biological remission, was associated with a better rate of endoscopic mucosal healing at 1 year than follow-up based solely on symptoms. Thus, the \"CALM\" strategy is considered to be the current benchmark.\n\nTransmural healing evaluated by MRI is also a promising objective associated with a reduced risk of progression (reappearance of symptoms, hospitalization, bowel resection). In addition, it could prevent intestinal destruction. A recent study by our team suggested that calprotectin (mucosal assessment) and MRI (transmural assessment) may be complementary and be a better therapeutic goal. We hypothesize that a \"CALM + MRI\" strategy concomitantly targeting transmural healing would be superior to the \"CALM\" strategy alone in maintaining clinical remission without corticosteroids in patients with CD treated with biotherapies.",[20,399,400],"Calprotectin","MRI","2026-07-29",{"date":226,"type":45},{"date":404,"type":45},"2022-03-21",{"date":406,"type":59},"2027-08-21",{"name":408,"class":83},"University Hospital, Clermont-Ferrand",17,{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":139,"enrollmentInfo":418,"targetDuration":4,"studyType":60,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":84},"100648823","a-specific-probiotic-in-the-modulation-of-gut-microbiota-of-patients-with-mild-to-moderate-ulcerative-colitis-100648823","NCT07724990","A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis","A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study","ANEMONE","Inclusion Criteria:\n\n* Men or women 18 to 80 years of age at the time of consent\n* Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening\n* Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore \\>1 based on endoscopic evaluation performed during screening phase\n* Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg\u002Fday of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening\n* Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.\n\nExclusion Criteria:\n\n* concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12\u002F23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced\u002Fbiological drugs (even if belonging to the same class) will be excluded.\n* Intolerance to topical therapy (enemas)\n* Allergy to A. muciniphila or any other component of the IP\n* Crohn's disease or inflammatory bowel disease unclassified (IBD-U)\n* Subject who received IV\u002Fintramuscular corticosteroids within 14 days prior to Screening or during the Screening period.\n* Subject who received topical therapy (i.e., enema or suppository of aminosalicylates \u002F corticosteroids) within 14 days prior to Screening or during the Screening period.\n* Subject who received fecal microbial transplantation within 3 months prior to Baseline.\n* Subjects with the following chronic or active infections:\n\n  * Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study\n  * Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice,\n  * Are infected with human immunodeficiency virus (HIV),\n  * Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.\n* Pregnancy and breastfeeding",{"count":419,"type":59},20,[62],"Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Although considered safe and easy to produce, they are not specifically designed to treat diseases, and no official health claims have been approved by EFSA. Advances in microbiome research have led to the discovery of Next-Generation Probiotics (NGPs), which are newly identified gut microbes associated with health and offer promising therapeutic potential despite lacking a long history of safe use.",[21,20],"2026-07-24",{"date":425,"type":45},"2026-07-27",{"date":427,"type":45},"2025-05-14",{"date":429,"type":59},"2027-05-14",{"name":431,"class":83},"Catholic University of the Sacred Heart",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":60,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":84},"100302608","phase-2-autologous-stem-cell-transplant-for-crohns-disease-100302608","NCT03219359","Autologous Stem Cell Transplant for Crohn's Disease","Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD)","Inclusion Criteria:\n\n* Diagnosis of Crohn's disease by standard criteria\n* Active disease based on clinical symptoms, defined as CDAI \\>250. In patients with an ostomy, the number of liquid stools score in the CDAI will be replaced by the number of times that the ostomy bag is emptied daily.\n* Active disease based on endoscopic evaluation, defined as SES-CD score \\> 3 in at least one bowel segment\n* Failure to respond to (or intolerant\u002Fadverse reaction to or declines) a member of each of the class of drugs listed below:\n\n  1. corticosteroids\n  2. azathioprine,\n  3. 6-mercaptopurine, methotrexate\n  4. Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)\n  5. Anti-integrin agents (natalizumab, vedolizumab)\n  6. Ustekinumab\n* Failure to respond refers to ongoing objective inflammation with symptoms and, as is traditional, is defined by the gastroenterologist evaluating the patient.\n* No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal\n\nExclusion Criteria:\n\n* History of significant toxicity to any medications used in trial (cyclophosphamide, thymoglobulin, vedolizumab)\n* Pregnant or breastfeeding\n* Age \\\u003C18\n* Karnofsky Performance Score \\\u003C60\n* Patients who have an uncontrolled infection (presumed or documented) despite appropriate therapy for at least one month\n* Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure.\n* HIV infected\n* Ejection fraction \\\u003C30% or requiring supplemental continuous oxygen.\n* DLCO \\\u003C35% or requiring supplementary oxygen.\n* Patients for whom an insufficient number of stem cells (\\\u003C2 X 10\\^6\u002Fkg) have been collected.",{"count":440,"type":59},50,[143],"Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant complications and discomfort in the stomach and intestines. Crohn's disease is a debilitating, incurable disease of immune cells; it affects almost 1 million people in the United States. CD is characterized by inflammation of the stomach and intestine as well as organs outside of the intestines such as the skin, eyes, and joints. Current therapies to treat CD aim to suppress the patient's immune cells but these therapies become ineffective for the majority of patients and lead to complications including the requirement for surgical bowel resection, impaired quality of life, and lifelong disability. Hematopoietic stem cell transplantation (HCT) is a procedure used to treat a number of medical conditions including Crohn's disease. To improve success of HCT in CD doctors considered combining transplant with other drugs to improve the chances of achieving remission and also maintaining the remission. The Investigators' plan in this study is to incorporate the drug Vedolizumab after transplant to test if this drug will improve remission and make patients healthier.\n\nPatients may qualify to take part in this research study because Crohn's disease is active, because surgery is not a treatment option and because there is evidence that the disease has failed to respond to treatments for Crohn's disease including the following:\n\n* corticosteroids\n* azathioprine, 6-mercaptopurine, methotrexate\n* Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)\n* Anti-integrin agents (natalizumab, Vedolizumab) If patients meet entry criteria will undergo a baseline endoscopy, colonoscopy and MR or CT enterography. If documentation of active mucosal disease patients will then be tapered off of current medications and undergo stem cell mobilization. Mobilization will involve low dose chemotherapy, growth factors and require 1-2 week hospitalization. Patients will then undergo stem cell transplant which will involve high dose chemotherapy and require a 2-4 week hospitalization. After restoration of the immune system patients will be placed on vedolizumab per standard dosing (0,2,6 then 8 every weeks) for a total of 8 doses. Patients will have monthly study visits and a repeat colonoscopy and MR\u002FCT scan at 6 months.",[20],[69,65,445,446,447,448],"Gastroenteritis","Crohn's disease","Colitis","Vedolizumab","2026-07-23",{"date":423,"type":45},{"date":452,"type":45},"2018-02-22",{"date":454,"type":59},"2028-10",{"name":456,"class":83},"Aaron Etra",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":60,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":84},"100628048","developing-a-self-management-intervention-to-improve-health-outcomes-for-patients-with-inflammatory-bowel-disease-100628048","NCT07456566","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial","Inclusion Criteria:\n\n* Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD\n* Impaired health-related quality of life\n* Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)\n* Fecal calprotectin \\> 250 microgram (ug\u002Fg)\n* Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60\n\nExclusion Criteria:\n\n* Unable to speak and read English\n* Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components\n* Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses\n* Are planned for imminent surgery\n* Have short bowel syndrome\n* Uncontrolled medical or psychiatric disease",{"count":465,"type":59},40,[62],"This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.\n\nThe study team hypothesizes:\n\n* the study will achieve a recruitment rate of 10 participants every 3 months\n* 70% participant retention at 24 weeks\n* 70% outcome data collection\n* 70% intervention completion\n* high acceptability",[65,21,20],[470,471,472,473],"Digital self-management program","Standard of care","Randomization","Questionnaires","2026-07-21",{"date":449,"type":45},{"date":477,"type":45},"2026-07-20",{"date":80,"type":59},{"name":480,"class":83},"University of Michigan",{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":488,"enrollmentInfo":489,"targetDuration":4,"studyType":60,"phases":490,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":84},"100606047","early-phase-1-cranberry-and-gut-health-in-crohns-disease-100606047","NCT07170462","Cranberry and Gut Health in Crohn's Disease","Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease","Inclusion Criteria:\n\n* Adult CD patients between 18 and 65 years old.\n* Women of childbearing potential will be required to use at least one form of \"highly effective\" contraception throughout the study.\n* Confirmed diagnosis of Crohn's disease.\n* CD activity lower than sCDAI\\\u003C450.\n* Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score \\\u003C60.\n* Stable dose of medications at screening; thiopurines, natalizumab, methotrexate (12 weeks), anti-TNF, ustekinumab (8 weeks), vedolizumab (8 weeks), 5-ASA (2 weeks),\n* steroids (1 week).\n* Willingness and capacity to significantly consume the cranberry supplement daily.\n* Willing and able to comply with specimen collection and other study procedures, and to complete the study.\n* Able to provide written informed consent.\n* Reside in Massachusetts, USA.\n\nExclusion Criteria:\n\n* Ostomy\n* Presence of symptomatic or significant stricture or history of obstruction in the past 6 months\n* Pregnancy\n* Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening\n* Use of probiotics within 4 weeks of screening\n* Use of antibiotics within 4 weeks of screening\n* \\> 20mg prednisone or equivalent\n* Recent C. difficile colitis\n* Unable to provide informed consent for themselves\n* Prisoners\n* Children","65 Years",{"count":440,"type":59},[491],"EARLY_PHASE1","This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's disease. People with Crohn's disease often have an imbalance in their gut microbiome (the community of bacteria in the gut). Previous research suggests that cranberry compounds may help support beneficial gut bacteria.\n\nIn this study, adults with Crohn's disease will be randomly assigned to one of two groups: one group will receive a cranberry supplement to take once daily for 10 weeks, and the other group will receive a placebo (a supplement with no active ingredients).\n\nAll participants will be asked to complete online questionnaires and collect samples of their blood, urine, and stool at four time points over a total of 15 weeks. These samples will help researchers understand how the cranberry supplement affects the gut microbiome, inflammation, and overall health.\n\nParticipation is voluntary, and participants can withdraw from the study at any time. The results of this study may help identify new diet-based approaches to improve gut health in individuals with Crohn's disease.",[494,20],"Crohn Disease (CD)",[496,497,498],"cranberry","dietary supplement","crohn disease","2026-07-17",{"date":477,"type":45},{"date":502,"type":45},"2025-10-29",{"date":504,"type":59},"2026-08-15",{"name":506,"class":83},"Ana Maldonado-Contreras",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":60,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":528},"100592786","phase-4-open-label-single-arm-study-to-assess-the-efficacy-of-mirikizumab-in-patients-with-inflammatory-strictures-due-to-cd-100592786","NCT06997965","Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD","An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease","MIRIAD","Inclusion Criteria:\n\n1. Nonpregnant, nonlactating adults, ≥ 18 years of age.\n2. Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening.\n3. Presence of at least 1 inflammatory stricture in the terminal ileum\\* within reach of an endoscope (passable or nonpassable). Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria:\n\n   * Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); AND\n   * Bowel wall thickening (≥ 25% relative to adjacent bowel; AND\n   * Either prestenotic dilation (defined as a luminal diameter ≥ 3 cm) or nonpassable with adult colonoscope \\*Note: The terminal ileum is defined as the last 15 cm of ileum proximal to the ileocecal valve or ileocolonic anastomosis. Other small bowel strictures will be considered on a case-by-case basis following discussion with the sponsor. Two strictures within 3 cm are considered the same stricture, and a long segment with multiple areas of narrowing or multiple strictures, that have inflammation between them, is counted as 1 stricture.\n4. Abdominal pain after eating and\u002For limitations in the amount\u002Ftypes of food eaten.\n5. Presence of tolerable obstructive symptoms and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study period. Participants should have sufficient food intake, even with diet modification, defined as a stable weight over 4 weeks prior to initiation of study intervention.\n6. Participants taking oral corticosteroids (eg, ≤ 20 mg\u002Fday prednisone or ≤ 9 mg\u002Fday budesonide) for ≥ 4 weeks prior to screening. Participants must be willing to undergo corticosteroid taper 8 weeks after initiation of study intervention as per standard of care.\n7. Participants can be on stable background therapy for CD and must agree to maintain the background therapy during the study. Acceptable stable background therapies include:\n\n   * Oral 5-ASA drugs or sulfasalazine ≤ 4.8 g per day, for ≥ 4 weeks prior to screening\n   * AZA, 6-MP, or MTX for ≥ 4 weeks prior to Screening\n   * Any rectal therapy for treatment of CD for ≥ 4 weeks prior to screening\n   * Antidiarrheal drugs for ≥ 8 weeks prior to screening\n   * Bile acid sequestrants for ≥ 4 weeks prior to screening\n8. Contraceptive use by study participants should be in accordance with the mirikizumab product monograph and local guidelines.\n9. Signed informed consent.\n\nExclusion Criteria:\n\n1. History or current diagnosis of UC, indeterminate colitis, ischemic colitis, nonsteroidal anti inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.\n2. CD-related complications:\n\n   * Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.\n   * Short bowel syndrome.\n   * Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.\n   * Inactive fistulae in or adjacent to an ileal stricture. Participants with perianal fistulae could be included provided there is no evidence of peri-anal abscess \\> 2 cm.\n   * Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated.\n   * Abscess located \\\u003C 2 cm in relation to the stricture.\n   * Toxic megacolon.\n3. Any major surgery, in the investigator's opinion, performed within 8 weeks prior to screening or planned during the study (ie, any surgical procedure requiring general anesthesia).\n4. Malignancies or history of malignancy within 5 years of the initial screening visit, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n5. Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury.\n6. Liver chemistry parameters that exceed the following thresholds:\n\n   * ALT or AST \\> 2 × ULN\n   * Alkaline phosphatase \\> 2.5 × ULN\n   * Total bilirubin \\> 1.5 × ULN\n7. Concomitant use of the following medications during the screening period or throughout the study:\n\n   * Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening.\n   * Biologics (anti-tumor necrosis factor, anti-integrins, ustekinumab, or risankizumab) within 8 weeks prior to screening.\n   * JAK inhibitor within 4 weeks prior to screening and throughout the study.\n   * IL23p19 inhibitor within 4 weeks (or 5 half-lives, whichever is longer) prior to screening, or a history of nonresponse or intolerance to IL23p19 inhibitors.\n8. Not up-to-date with current age-appropriate vaccinations in accordance with current immunization guidelines and the investigator's usual standard of care at screening.\n9. Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening.\n10. Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies.\n11. Systemic or opportunistic infections including:\n\n    * HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to Day 0, retesting is not required.\n    * Known active or latent TB; if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before Day 0.\n    * Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin).\n    * Active CMV infection, as per investigator judgement\n    * Other systemic or opportunistic infection, any other clinically significant extraintestinal infection, infection that is not responding to standard treatment, or recurring infection within 6 months of Day 1.\n12. Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients.\n13. Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic.\n14. Prior enrolment in the current study and had received study treatment.\n15. Any acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study intervention administration, or may interfere with the interpretation of study results, as determined by the investigator.\n16. Unwillingness to withhold protocol-prohibited medications during the trial.",{"count":141,"type":59},[246],"This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.",[20],"2026-07-15",{"date":521,"type":45},"2026-07-16",{"date":523,"type":45},"2026-04-20",{"date":525,"type":59},"2028-04-01",{"name":527,"class":83},"Alimentiv Inc.",5,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":84},"100647640","evaluation-of-the-accuracy-of-immunostaining-of-claudin-2-to-detect-active-or-inactive-inflammation-in-endoscopic-biopsies-of-ibd-100647640","NCT07710287","Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD","Histologic Healing in IBD: Comparison of \"Standard\" Scores With Expression of Claudin 2 and Impact on Outcomes","LOGIC-2","Inclusion Criteria:\n\nConfirmed diagnosis of IBD\n\nExclusion Criteria:\n\nUnconfirmed diagnosis of IBD",{"count":538,"type":59},100,"In view of the increasing evidence of the importance of mucosal healing as a combination of endoscopic and histologic healing, and the complexity and lack of complete agreement of the evaluation of histologic healing in IBD, the aim of this study will be to evaluate the accuracy of a new methodology, the immunostaining for Claudine 2 as compared to others standard well-accepted scoring for histologic activity in IBD. The aim is compare the accuracy of this methodology and in addition the correlation with outcomes (i.e. relapse, hospitalization, surgery).",[541,20],"Ulcerative Colitis (UC)",[543,446,544,545,546],"Ulcerative colitis","Histology","Mucosa healing","Claudin","2026-07-13",{"date":499,"type":45},{"date":550,"type":45},"2025-02-14",{"date":552,"type":59},"2027-09",{"name":554,"class":83},"IRCCS Policlinico S. Donato",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":114,"sex":16,"minAge":563,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":60,"phases":566,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":84},"100463981","fecal-microbiota-transplantation-as-the-first-line-treatment-in-active-pediatric-crohns-disease-100463981","NCT05321758","Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease","Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease","FMT","Inclusion Criteria:\n\nage of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of \\>10 and ≤40, and SES-CD of \\>3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy\n\nExclusion Criteria:\n\npatients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment","2 Years","16 Years",{"count":440,"type":59},[62],"To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.",[20],[570],"Crohn Disease;fecal microbiota transplantation","2026-07-09",{"date":573,"type":45},"2026-07-10",{"date":575,"type":45},"2020-03-22",{"date":577,"type":59},"2027-06-30",{"name":579,"class":83},"Tongji Hospital",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":561,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":16,"minAge":563,"maxAge":564,"enrollmentInfo":587,"targetDuration":4,"studyType":60,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":84},"100463980","fecal-microbiota-transplantation-in-pediatric-crohns-disease-100463980","NCT05321745","Fecal Microbiota Transplantation in Pediatric Crohn's Disease","Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease","Inclusion Criteria:\n\nAged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) \\>10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) \\> 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics)\n\nExclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent\u002Fassent",{"count":465,"type":59},[62],"This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment",[20],[592],"fecal microbiota transplantation , Crohn Disease",{"date":573,"type":45},{"date":595,"type":45},"2022-03-22",{"date":597,"type":59},"2027-05-31",{"name":599,"class":83},"Biao Zou"]