[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflamatory-bowel-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflamatory-bowel-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,51,81,107,132,166,188,206,227,260],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100652121","non-nutritive-sweeteners-in-inflammatory-bowel-disease-100652121",false,"NCT07769437","Non-nutritive Sweeteners in Inflammatory Bowel Disease","The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease","Inclusion Criteria:\n\nAge range from: 18 to 70 years. Male or female. Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (\\\u003C6 score).\n\nCapable of providing consent to participate. Able to complete daily surveys and take oral nutrition. Able to record meal intake. Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).\n\nExclusion Criteria:\n\nShort bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.\n\nKnown drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture\u002Fnarrowing. Presence of an ostomy. Known active malignancy. Antibiotic use within last 14 days. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of \\\u003C1 natural bowel movements per 3 consecutive days. Unable to access to technology that permits the daily completion of study related activities.\n\nChange in IBD medication within past 4 weeks. Body mass Index \\\u003C18 kg\u002Fm or ≥35 kg\u002Fm. Documented C.difficile colitis within four weeks of screening. Bariatric surgery Phenylketonuria",true,"ALL","18 Years","70 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study will focus on the commonly used non-nutritive sweetener (NNS) sucralose (2 sachets\u002Fday resulting in daily dose: sucralose 2.5mg\u002Fkg) and its role in changing the gut microbiota in humans with IBD, compared to healthy non-IBD individuals. We will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).",[28,29],"Inflamatory Bowel Disease","Crohn Disease (CD)",[31,32,33,34,35,36,37],"sweeteners","sucralose","inflammatory bowel disease","crohn's disease","IBD","CD","artificial sweeteners","RECRUITING","2026-08-11",{"date":41,"type":42},"2026-08-18","ACTUAL",{"date":44,"type":42},"2025-02-03",{"date":46,"type":22},"2026-12",{"name":48,"class":49},"University Hospitals Cleveland Medical Center","OTHER",3,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100648502","screening-questionnaires-and-musculoskeletal-ultrasound-for-early-detection-of-spondyloarthritis-in-ibd-patients-100648502","NCT07721844","Screening Questionnaires and Musculoskeletal Ultrasound for Early Detection of Spondyloarthritis in IBD Patients","Incremental Value of Musculoskeletal Ultrasound After DETAIL and IBIS-Q Screening for Early Detection of IBD-associated Spondyloarthritis.","IBD-MSUS","Inclusion Criteria:\n\nAdult Aged 18 years old or more Confirmed diagnosis of IBD (by established clinical, endoscopic, and histopathological criteria).\n\nPatient provides informed written consent to participate\n\nExclusion Criteria:\n\nKnown, pre-existing diagnosis of Spondyloarthritis or any other concomitant systemic autoimmune rheumatic disease.\n\nSevere secondary osteoarthritis or major joint trauma\u002Fsurgery mimicking SpA. Cognitive impairment or communication barriers preventing comprehension or completion of questionnaires",{"count":60,"type":22},200,"OBSERVATIONAL","This study aims to evaluate the screening performance of the DETAIL and IBIS-Q questionnaires followed by musculoskeletal ultrasound (MSUS) for the early detection of spondyloarthritis in patients previously diagnosed with Inflammatory Bowel Disease (IBD).",[28,64],"Spondylarthritis",[66,67,68,69,35],"DETAIL questionnaire","IBIS-Q questionnaire","Musculoskeletal ultrasound","Screening","NOT_YET_RECRUITING","2026-07-19",{"date":73,"type":42},"2026-07-23",{"date":75,"type":22},"2026-09-01",{"date":77,"type":22},"2027-12-01",{"name":79,"class":49},"Assiut University",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":80},"100646207","comparison-of-the-efficacy-of-different-biologic-agents-in-preventing-postoperative-endoscopic-recurrence-of-crohns-disease-100646207","NCT07694674","Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings.\n* Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection.\n* Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery.\n* Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months.\n* Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence.\n\nExclusion Criteria:\n\n* Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy.\n* Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy.\n* No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment.\n* Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate.\n* Other conditions considered by the investigators to be inappropriate for inclusion.","85 Years",{"count":89,"type":22},198,"This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD). It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery. The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat. Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent. Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.",[28,29],[93,94,95,96,97],"Crohn's disease","biologics","postoperative","recurrence","efficacy","2026-07-06",{"date":100,"type":42},"2026-07-10",{"date":102,"type":42},"2026-01-16",{"date":104,"type":22},"2026-10-31",{"name":106,"class":49},"Shanghai 10th People's Hospital",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":115,"maxAge":18,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":80},"100633992","fecal-microbiome-signature-of-multi-strain-probiotics-supplementation-in-children-and-adolescents-with-inflammatory-bowel-disease-100633992","NCT07533890","Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease","Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease - an Explanatory 1:1 Randomized Controlled Cross-Over Proof-of-Concept Trial With Blinded Outcome Assessment","MicroSig","Inclusion Criteria:\n\n* Signed informed consent\n* Diagnosis of inflammatory bowel disease according to actual guidelines (Porto Criteria)\n* General good health\n* Ability to understand and follow study procedures and understand informed consent\n* Age 5 -18 years\n* No probiotic therapy 4 weeks before entering into the study.\n\nExclusion Criteria:\n\n* Participation in other clinical studies interfering with study procedures.\n* Inability or contraindications to undergo the investigated intervention\n* Severe or acute flare of disease (for UC PUCAI score ≥35, for CD wPCDAI \\>40)\n* Treatment escalation within last 4 weeks for uncontrolled disease.\n* Antibiotic or probiotic therapy within the last 4 weeks.","5 Years",{"count":21,"type":22},[25],"In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.",[28],[121,33,122],"microbiome","probiotics","2026-06-29",{"date":125,"type":42},"2026-06-30",{"date":127,"type":42},"2026-05-01",{"date":129,"type":22},"2028-12",{"name":131,"class":49},"Insel Gruppe AG, University Hospital Bern",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":80},"100630203","physical-activity-and-fitness-in-pediatric-inflammatory-bowel-disease-100630203","NCT07484620","Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease","Effects of Physical Activity and Physical Fitness on Inflammation, Clinical Outcomes, and Quality of Life in Pediatric Inflammatory Bowel Disease","PAFIT-IBD","Inclusion Criteria:\n\n* Children and adolescents aged 6 to 17 years\n* Confirmed diagnosis of Crohn's disease or ulcerative colitis\n* Clinical remission or mild-to-moderate disease activity\n* Medical clearance to participate in physical activity\n* Ability to complete study assessments and follow-up procedures\n* Written informed consent from a parent or legal guardian and assent from the participant\n\nExclusion Criteria:\n\n* Severe disease activity or acute flare requiring hospitalization\n* Medical contraindications to exercise (e.g., severe cardiopulmonary disease, uncontrolled anemia, significant musculoskeletal conditions)\n* Major surgery within the previous 3 months\n* Participation in another interventional clinical trial\n* Cognitive or behavioral conditions preventing participation\n* Any condition considered unsafe by the investigators or treating physician","6 Years","17 Years",{"count":143,"type":22},100,[25],"Pediatric inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic condition associated not only with intestinal inflammation but also with reduced physical fitness, fatigue, impaired quality of life, and psychosocial difficulties. Although physical activity and physical fitness are recognized as important determinants of health in the general pediatric population, their role as modifiable prognostic factors in children and adolescents with IBD remains insufficiently studied, particularly using objective measures and longitudinal designs in hospital settings.\n\nThe present hospital-based study aims to investigate the effects of physical activity and physical fitness on inflammation, clinical outcomes, and quality of life in children and adolescents with IBD. The project comprises three phases: (1) an observational cross-sectional and longitudinal assessment, (2) a randomized controlled trial (RCT) evaluating a structured physical activity intervention, and (3) a medium-term follow-up at 6-12 months.\n\nPhysical activity will be assessed objectively using accelerometry and subjectively using validated questionnaires. Physical fitness will be evaluated with the ALPHA fitness battery adapted to the hospital setting, with cardiorespiratory fitness assessed by the 20-meter shuttle run test as the primary outcome of the RCT. Clinical outcomes will include objective inflammatory markers (fecal calprotectin and C-reactive protein), disease activity indices (PCDAI or PUCAI), musculoskeletal health, fatigue, cognitive functioning, and health-related quality of life. Nutritional status and dietary quality will also be assessed, and selected biological markers will be analyzed in a subsample.\n\nThe RCT will examine whether a 12-week supervised physical activity program improves cardiorespiratory fitness compared with usual care, and whether changes in fitness are accompanied by improvements in inflammatory burden and patient-reported outcomes. Longitudinal analyses will explore the sustainability of these effects over time.\n\nThis study will provide comprehensive, objective evidence on the role of physical activity and physical fitness as modifiable factors in pediatric IBD. The results are expected to inform clinical practice, support the integration of structured physical activity into multidisciplinary care, and contribute high-quality data for publication in international peer-reviewed journals.",[147,28],"Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)",[149,150,151,152,153,154,155,156],"Pediatric Inflammatory Bowel Disease","Health-Related Quality of Life","Fecal Calprotectin","Physical Fitness","Cardiorespiratory Fitness","Accelerometry","Cognitive Function","Disease Activity","2026-03-19",{"date":159,"type":42},"2026-03-24",{"date":161,"type":22},"2026-04-01",{"date":163,"type":22},"2026-12-01",{"name":165,"class":49},"Universidad Complutense de Madrid",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":172,"enrollmentInfo":173,"targetDuration":175,"studyType":61,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":80},"100630423","a-prospective-observational-study-on-the-efficacy-and-safety-of-guselkumab-in-the-treatment-of-crohns-disease-patients-previously-treated-with-ustekinumab-100630423","NCT07487480","A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab","Inclusion Criteria:\n\n* Age 18-75 years.\n* Diagnosis of Crohn's disease for at least 3 months.\n* Moderate to severe disease activity (CDAI 220-450).\n* Previous treatment with at least one standard dose of ustekinumab with documented:\n* Primary non-response, or Secondary loss of response, or Intolerance leading to discontinuation.\n* Willing and able to comply with all study visits and procedures.\n\nExclusion Criteria:\n\n* Previous exposure to any anti-IL-23p19 therapy (including guselkumab).\n* Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or recent abdominal abscess (\\\u003C8 weeks).\n* History of malignancy (except certain skin cancers), active tuberculosis, or severe opportunistic infection.\n* Pregnancy, lactation, or planned pregnancy during the study period.","75 Years",{"count":174,"type":22},60,"2 Years","This is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Participants will receive guselkumab treatment following a defined induction and maintenance regimen over a total observation period of 52 weeks. The primary endpoint is the proportion of patients achieving clinical remission at Week 52. Secondary endpoints include clinical response, endoscopic improvement, biomarker normalization, quality of life assessment, and safety monitoring.",[28,178],"Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)","2026-03-17",{"date":181,"type":42},"2026-03-23",{"date":183,"type":42},"2025-02-10",{"date":185,"type":22},"2028-12-31",{"name":187,"class":49},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":205,"locationsCount":80},"100630410","a-prospective-cohort-study-evaluating-the-efficacy-and-safety-of-guselkumab-gus-with-jak-inhibitors-in-patients-with-difficult-to-treat-inflammatory-bowel-disease-ibd-100630410","NCT07487311","A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)","Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD","Inclusion Criteria:\n\n* Age 14-80 years with confirmed diagnosis of IBD;\n* Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2);\n\n  * Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2);\n  * Signed informed consent.\n\nExclusion Criteria:\n\n* Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation;\n\n  * History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia;\n  * Prior intolerance to JAK inhibitors or IL-23 inhibitors.","14 Years","80 Years",{"count":198,"type":22},80,"Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib\u002Ftofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.",[28],{"date":181,"type":42},{"date":203,"type":42},"2026-01-07",{"date":185,"type":22},{"name":187,"class":49},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":224,"leadSponsor":226,"locationsCount":4},"100624957","phase-1-safety-and-efficiency-of-the-universal-cnk-ut009-in-difficult-to-treat-inflammatory-bowel-disease-patients-100624957","NCT07416383","Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients","An Exploratory Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetics of the Universal CNK-UT009 Cell Injection in Subjects With Difficult-to-treat Inflammatory Bowel Disease","Inclusion Criteria:\n\n* diagnosed moderate-to- severe IBD patients\n* defiened as difficult-to-treat(failed from at least two types of biologics or small molecular drugs, or refractory from at least twice of intestinal surgery)\n* with complete bone-marrow and organic function\n* no pregnant or planning to become pregnant\n* welling to paticipate\n\nExclusion Criteria:\n\n* patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)\n* patients paticipated other clinical trials with four weeks\n* patients with drug combination other than low-dose glucocotiod\n* patients recieved abdominal surgery or live vaccine\n* patients with planned surgery in three months\n* unsuitable situations determined by researchers","65 Years",{"count":21,"type":22},[216],"PHASE1","Inflammatory bowel disease patients who failed from at least two types of biologics or suffered refractory after at least twice surgery are defiened as difficult-to-treat IBD. It is reported a low five-year suvival rate around 15% of difficult-to-treat IBD patients. Cell therapy is a promising new strategy in auto-immune diseases beyond malignant cancers. Inbalanced immune microenvironment contribute to IBD and cell therapy should be a brighting selection of difficult-to-treat IBD. CNK-UT009 is an universal cellular immunotherapy targeted to auto-reactive T cells whose safety and effect were proved in patients with GVHD and type 1 diabetes mellius. Here, we conducted a single-arm open-label exploratory clinical study of CNK-UT cell therapy on difficult-to-treat IBD patients, mainly to explore the safety and define the maximum tolerated dose. Besides, the preliminary effect would also be evaluated.",[28,29,219],"Ulcerative Colitis (UC)","2026-02-14",{"date":222,"type":42},"2026-02-18",{"date":161,"type":22},{"date":225,"type":22},"2031-12-31",{"name":187,"class":49},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":80},"100613945","early-phase-1-68ga-fapi-46-petct-for-assessing-small-bowel-fibrostenosis-in-crohns-disease-100613945","NCT07273188","68Ga-FAPI-46 PET\u002FCT for Assessing Small Bowel Fibrostenosis in Crohn's Disease","Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPI-46) PET in Crohn's Disease Patients: a Case-control Study Designed to Illuminate the Spectrum of Fibrostenosis in Patients With Small Bowel Crohn's Disease","FAPI-PETCD","Inclusion Criteria:\n\n* Known small bowel Crohn's disease\n* Research or clinical MR enterography, or clinical CT enterography, within 3 months.\n* Male or female with age greater than 18 years old.\n* Diagnosis of Crohn's disease by a gastroenterologist\n* Willingness to undergo 68Ga-FAPI-46 PET\u002FCT\n* Subjects with the capacity to give informed consent and willingness to provide written consent\n\nExclusion Criteria:\n\n* Pregnant and\u002For breast-feeding subjects.\n* Hypersensitivity to any excipients in 68Ga-FAPI-46",{"count":236,"type":22},45,[238],"EARLY_PHASE1","This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. The goal is to determine whether areas of early or developing fibrosis (\"pre-stricture\" changes) demonstrate uptake of the tracer, which binds to fibroblast activation protein (FAP).\n\nParticipants with small bowel Crohn's disease will be assigned to either a case or control group based on CT or MR enterography findings at enrollment.\n\nCases will include participants who have a small bowel stricture or probable stricture, with or without penetrating complications.\n\nControls will include participants with small bowel Crohn's disease without strictures. Controls may have active inflammatory disease, luminal narrowing, or no active inflammation (including postoperative or chronic changes), as long as no stricture is present.\n\nBecause most radiologic strictures represent more advanced fibrostenosis, the study aims to enroll a larger proportion of controls to better characterize early fibrotic changes. Approximately one-third to one-half of participants will be cases, and the remainder controls. This design will allow comparison of FAPI uptake patterns in patients with and without strictures to understand how FAP expression relates to the development of small bowel fibrosis.",[241,242,28,243],"Crohn's Disease","Intestinal Fibrosis","Intestinal Strictures Related to Crohn´s Disease",[245,246,247,248,249,250],"Ga68-FAPI-46","PET\u002FCT","Small bowel stricture","Fibrostenosis","FAPI PET","Small bowel Crohn's disease","2026-02-05",{"date":253,"type":42},"2026-02-09",{"date":255,"type":42},"2026-01-26",{"date":257,"type":22},"2027-04-30",{"name":259,"class":49},"Mayo Clinic",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":80},"100606897","construction-and-validation-of-a-predictive-model-for-the-efficacy-of-different-biologics-in-inflammatory-bowel-disease-100606897","NCT07181525","Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Patients who are clinically diagnosed with IBD in our hospital\n* Disease activity is in the active stage\n* Receiving biologics after diagnosis\n* Have relevant data on clinical evaluation results after receiving biologics treatment\n\nExclusion Criteria:\n\n* IBD patients who have not been treated with biologics after diagnosis\n* Patients diagnosed with IBD but also with other autoimmune diseases that require biologics to be treated\n* Patients with hematological diseases and other systemic chronic inflammatory diseases involving the intestine Patients with serious complications including malignant tumors and gastrointestinal perforation.",{"count":60,"type":22},"Inflammatory bowel disease (IBD) is a group of chronic progressive gastrointestinal diseases that can recur throughout life and for which there is no cure. Biologics, the first line of treatment, are not only expensive, but also 30-50% of patients lack response to this type of drug therapy. However, there is a lack of reliable methods to predict the clinical efficacy of biologics. The aim of this study is to construct a reliable model to predict patients' response to biologics therapy by comprehensively analysing patients' clinical characteristics, biomarkers and other information to guide individualized therapy. In this study, we will collect clinical data from IBD patients at Peking University First Hospital, including but not limited to patients' baseline characteristics, biomarker levels, and efficacy responses, etc. We will establish a complete patient dataset using a cohort study, train and test the dataset by applying correlation analysis, multiple regression analysis, and machine learning algorithms (e.g. neural networks etc), establish and compare the prediction effects of different models The optimal model is selected for encapsulation and developed into a user-friendly clinical prediction tool. This study will contribute to clinical decision making for IBD patients, improve treatment outcomes, and reduce unnecessary healthcare costs.",[28],[33,270,94],"machine learning","2025-09-11",{"date":273,"type":42},"2025-09-18",{"date":275,"type":42},"2025-08-15",{"date":277,"type":22},"2026-12-31",{"name":279,"class":49},"Peking University First Hospital"]