[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-bowel-diseases-ibd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-bowel-diseases-ibd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,58,84,121,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100646737","ibd-biomarker-discovery-and-validation-platform-100646737",false,"NCT07686406","IBD Biomarker Discovery and Validation Platform","Biomarker Discovery, Validation, and Multi-Omics Profiling for Disease Activity Assessment, Treatment Monitoring, and Risk Stratification in Inflammatory Bowel Disease: A Multicenter Prospective Biospecimen-Based Observational Cohort Study","IBD-BIOP","Eligibility Criteria:\n\nInclusion Criteria:\n\n1. General inclusion criteria for all participants:\n\n   * Age 14 years or older.\n   * Able to provide written informed consent; for minors, consent from a legal guardian and assent from the participant will be obtained according to local ethics requirements.\n   * Willing to provide clinical information and\u002For biospecimens, which may include blood, stool, intestinal tissue, or other available biological samples.\n   * Able to participate in study-related data and sample collection according to the study protocol.\n2. Participants with inflammatory bowel disease:\n\n   * Diagnosed with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified when applicable, according to accepted national or international diagnostic criteria.\n   * May be newly diagnosed, previously diagnosed, under routine follow-up, or receiving routine clinical treatment.\n   * Clinical data, treatment exposure information, laboratory results, endoscopic findings, histologic findings, imaging findings, biospecimens, and follow-up outcomes may be available or collected.\n3. Unaffected first-degree relatives of participants with inflammatory bowel disease:\n\n   * Biological first-degree relatives of participants with inflammatory bowel disease, including parents, siblings, or offspring.\n   * No prior diagnosis of inflammatory bowel disease at enrollment.\n   * Willing to provide clinical information and\u002For biospecimens for family-based genetic, environmental, immune, microbiome, and multi-omics analyses.\n4. Unrelated healthy controls:\n\n   * Individuals without a diagnosis of inflammatory bowel disease.\n   * No first-degree biological relationship to enrolled participants with inflammatory bowel disease.\n   * No known active gastrointestinal inflammatory disease at enrollment.\n5. Non-IBD disease controls:\n\n   * Individuals with gastrointestinal symptoms or other non-IBD conditions who undergo clinical evaluation but are not diagnosed with inflammatory bowel disease.\n   * Clinical information and\u002For biospecimens may be collected as disease controls when appropriate.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent or required assent when applicable.\n* Active severe infection or chronic infectious disease that may substantially affect biomarker interpretation, including active tuberculosis, active hepatitis B or C, HIV infection, or other clinically significant active infection.\n* Pregnancy or lactation at the time of enrollment.\n* Severe mental illness, cognitive impairment, or other condition that prevents cooperation with study procedures.\n* Known primary extraintestinal autoimmune disease or systemic inflammatory disease that is considered the main disease and may substantially confound biomarker interpretation.\n* Current or recent participation in another interventional clinical trial that may substantially affect the study biomarkers or outcome assessments, as judged by the investigator.\n* History of malignant tumor or other severe comorbidity that may substantially affect study participation or biomarker interpretation, as judged by the investigator.\n* Inadequate biospecimen quality, missing key clinical information, or inability to complete essential study assessments for the relevant analysis.",true,"ALL","14 Years",{"count":21,"type":22},6000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to establish a multicenter prospective clinical and biospecimen platform for biomarker discovery and validation in inflammatory bowel disease, including Crohn's disease and ulcerative colitis.\n\nResearchers want to learn whether candidate biomarkers or combined biomarker models can help assess intestinal inflammation, monitor response to routine clinical treatment, predict treatment outcomes, and identify participants who may be at higher risk of disease progression.\n\nThe study may enroll participants with inflammatory bowel disease, unaffected first-degree relatives of participants with inflammatory bowel disease, unrelated healthy controls, and non-IBD disease controls when appropriate. Clinical information and biological samples, including blood, stool, and intestinal tissue, may be collected. Biomarkers measured in blood, stool, intestinal tissue, genetic data, immune profiles, microbiome data, and other multi-omics data may be evaluated.\n\nThe main questions this study aims to answer are:\n\nCan candidate biomarkers or combined biomarker models identify endoscopic disease activity when compared with endoscopic assessment?\n\nCan these biomarkers monitor or predict clinical response, clinical remission, endoscopic response, endoscopic remission, imaging response, or biomarker response during routine clinical care?\n\nCan these biomarkers help predict treatment failure, disease progression, hospitalization, surgery, treatment escalation, or complex Crohn's disease phenotypes?\n\nParticipants will not be assigned to any treatment by the study. All treatments and clinical management decisions will be chosen by treating physicians as part of routine medical care.",[26,27,28],"Crohn Disease (CD)","Ulcerative Colitis (UC)","Inflammatory Bowel Diseases (IBD)",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Biomarker discovery","Biomarker validation","Prospective observational cohort Disease activity","Endoscopic activity","Histologic activity","Treatment monitoring","Treatment response","Risk stratification","Disease progression","Leucine-rich alpha-2 glycoprotein","Fecal calprotectin","Oncostatin M","TL1A","TNFSF15","Multi-omics","RECRUITING","2026-06-28",{"date":48,"type":49},"2026-07-07","ACTUAL",{"date":51,"type":49},"2022-01-01",{"date":53,"type":22},"2028-12-31",{"name":55,"class":56},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",2,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":17,"sex":18,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100644521","epidemiological-evaluation-of-chronic-kidney-disease-in-pediatric-patients-with-inflammatory-bowel-disease-100644521","NCT07670988","Epidemiological Evaluation Of Chronic Kidney Disease In Pediatric Patients With Inflammatory Bowel Disease","A Multicenter, Cross-sectional Observational Study for the Epidemiological Evaluation of Chronic Kidney Disease in Pediatric Patients With Inflammatory Bowel Disease, and Its Relationship With Disease Activity and Medical Therapy.","KIBD","Inclusion Criteria:\n\n* Pediatric patients aged between 2 and 17 years\n* For the case group: confirmed diagnosis of inflammatory bowel disease according to Porto criteria\n* For the control group: absence of current or previous diagnosis of inflammatory bowel disease\n* Availability of clinical and laboratory data required for study evaluation\n* Written informed consent from parent or legal guardian, and assent from the minor when applicable\n\nExclusion Criteria:\n\n* History of pre-existing renal disease (congenital or acquired before IBD diagnosis)\n* Presence of conditions that may affect renal function (e.g., diabetes mellitus, hypertension, chronic use of nephrotoxic drugs)\n* Lack of informed consent","2 Years","17 Years",{"count":69,"type":22},600,"This multicenter observational cross-sectional study aims to evaluate the prevalence of chronic kidney disease (CKD) in pediatric patients with inflammatory bowel disease (IBD) and to compare it with a control group without IBD.\n\nInflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are chronic conditions that can also affect organs outside the intestine. Among these, kidney involvement has been reported, but data in pediatric populations are limited.\n\nThe study will collect clinical, laboratory, and demographic data from pediatric patients with IBD and matched controls without IBD. The main objective is to estimate the prevalence of CKD in children with IBD and compare it with that observed in the control group. Secondary objectives include describing patient characteristics and exploring potential associations between CKD, disease activity, and medical therapies.\n\nThe results of this study may improve the understanding of kidney complications in pediatric IBD and support earlier diagnosis and better clinical management.",[28],[73],"Pediatric IBD","2026-06-22",{"date":76,"type":49},"2026-06-26",{"date":78,"type":22},"2026-09-01",{"date":80,"type":22},"2027-01",{"name":82,"class":56},"Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":18,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":83},"100634782","phase-1-bcma-cd19-ccar-t-for-the-treatment-of-refractory-inflammatory-bowel-disease-ibd-100634782","NCT07544160","BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)","A Single-arm, Open-label Phase I Clinical Study to Evaluate ICG318 CAR-T in Adults With Refractory Inflammatory Bowel Disease","Key Inclusion criteria:\n\n1. All subjects or legal guardians must sign an ethics committee-approved informed consent form in writing prior to initiation of any screening procedures.\n2. Male or female subject over 18 years old and under 70 years old at the time of evaluation; Weight ≥ 40 kg.\n3. Diagnosed with inflammatory bowel disease assessed by the investigator and the disease course has been ≥ 3 months before signing informed consent (clinical manifestations, endoscopy and histopathological reports consistent with the diagnosis of inflammatory bowel disease are required).\n4. The subject has documented inadequate response, loss of response, or intolerance to at least one advanced therapy for IBD.\n5. Patients with IBD during the screening period need to meet the requirements of moderate to severe IBD; UC: active ulcerative colitis, defined as per the adapted Mayo score criteria. CD: CD subjects with moderate to severe active CD, defined as interpreted by SES-CD.\n6. Life expectancy greater than 6 months;\n7. Female individuals with fertility (defined as all females who are physiologically capable of becoming pregnant) must provide informed consent, have a negative blood pregnancy test result, and agree to use highly effective contraception from the time of informed consent until 1 year after CAR-T cell infusion. Male individuals with fertility must agree to use effective barrier contraception from the time of informed consent until 1 year after CAR-T cell infusion, and should not donate semen or sperm during the entire study period.\n8. Indeterminate colitis is permitted.\n\nKey Exclusion criteria:\n\n1. Subjects who have previously received any BCMA and\u002For CD19 targeted cell therapy products or CAR-T therapy for any target before signing the informed consent form.\n2. Undiagnosed type colitis, fulminant colitis, Hirschsprung-associated enterocolitis (HAEC), microscopic colitis, ischemic colitis, radiation colitis, colitis-related diverticular disease, or other colitis or enteritis type that may confound the evaluation of efficacy.\n3. Subjects with malignant tumors or dysplasia on endoscopy.\n4. Subjects with severely impaired vital organ function.\n5. Impaired bone marrow function.\n6. Active hepatitis B, HCV positive, HIV antibody positive, Treponema pallidum antibody positive, Active tuberculosis.\n7. Presence of any IBD related complications determined by the investigator to interfere with the study of ICG318 CAR-T in refractory IBD.\n8. History of bleeding within 30 days determined by the investigator to exclude the patient.\n9. Infectious diseases: subjects with acute, life-threatening bacterial, viral or fungal infections that have not been controlled.\n10. Hospitalization for IBD-related complications within 30 days prior to screening.\n\n11） Clinically significant central nervous system disease determined by the investigator to impair the subjects ability to participate safely in this trial.\n\n12） Subjects with prior or concurrent malignancies. Exceptions may be determined at the discretion of the investigator.\n\n13） Vaccination within 30 days before screening and vaccination within 3 months after planned cell ICG318 CAR-T infusion.\n\n14） Subjects who are receiving or have received another investigational drug or drugs without adequate washout time as determined by the principal investigator.\n\n15） Those who are judged by the investigator to be unfit for leukapheresis, or whose IBD disease severity and trajectory are not compatible with infusion with ICG318 CAR-T cells, or any critical steps of the trial evaluation such as but not limited to contraindications to colonoscopy.\n\n16） Female subjects who are pregnant or lactating. 17） Autoimmune diseases judged by the investigator to require systemic treatment and affect the evaluation of efficacy.\n\n18） Suicidal tendencies, tobacco use, substance use, or alcohol abuse as determined by the investigator.\n\n19） Those who have a history of a severe drug allergy, or are allergic to the test drug ingredients, excipients or combined therapeutic drugs.\n\n20） Other conditions that the investigator believes should not participate in this clinical trial.","18 Years","70 Years",{"count":94,"type":22},18,"INTERVENTIONAL",[97,98],"PHASE1","PHASE2","This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15\u002FIL15sushi cCAR T cells) in patients with relapsed and\u002For refractory inflammatory bowel disease.",[28],[102,103,104,105,106,107,108,109],"Ulcerative Colitis","Crohn's disease","Inflammatory Bowel Disease","IBD","UC","CD","CAR-T","Cellular Therapy","NOT_YET_RECRUITING","2026-04-15",{"date":113,"type":49},"2026-04-22",{"date":115,"type":22},"2026-04-07",{"date":117,"type":22},"2028-04-07",{"name":119,"class":120},"iCell Gene Therapeutics","INDUSTRY",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":95,"phases":130,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":83},"100578022","study-of-tissue-repair-in-inflammatory-bowel-disease-exploiting-organoid-technology-100578022","NCT06805890","Study of Tissue Repair in Inflammatory Bowel Disease Exploiting Organoid Technology","ORGANOIDS","For IBD group the inclusion criteria will be:\n\n* Patients of either sex aged 18 years or older\n* Patient that have read the information form and signed consent\n* Patient covered with health insurance\n* Patients with Crohn's Disease or ulcerative colitis in accordance with accepted clinical, endoscopic, histological and\u002For radiologic criteria, regardless of the level, severity of the disease or duration of disease progression.\n* Patients with colonic involvement of Crohn's disease or ulcerative colitis\n* Patients undergoing a screening colonoscopy in the context of IBD disease follow-up OR undergoing intestinal resection for IBD disease aggravation\n\nFor control group the inclusion criteria will be:\n\n* Patients of either sex aged 18 years or older\n* Patient that have read the information form and signed consent\n* Patient covered with health insurance\n* Patients undergoing a screening colonoscopy in the context of a family history of colonic neoplasia, follow-up of colonic polyps or functional intestinal disorders OR undergoing intestinal resection for intestinal neoplasia, occlusive syndrome or colostomy\n\nThe non-inclusion criteria for IBD group will be:\n\n* Contraindication to the anaesthetic or colonoscopy procedure\n* Patients without colonic involvement of Crohn's disease or ulcerative colitis\n* Patients of Adults without legal capacity\n* Patients in Health and Social Establishments\n* Persons in emergency situations\n* Persons deprived of their liberty\n* Non-affiliated to a social security scheme\n* Absence or refusal of the informed consent\n\nThe non-inclusion criteria for control group will be:\n\n* IBD disease revealed during colonoscopy or gastrointestinal resection\n* Patient suffering from Immune-Mediated Inflammatory Diseases (IMIDs)\n* Contraindication to the anaesthetic or colonoscopy procedure\n* Patients of Adults without legal capacity\n* Patients in Health and Social Establishments\n* Persons in emergency situations\n* Persons deprived of their liberty\n* Non-affiliated to a social security scheme\n* Absence or refusal of the informed consent",{"count":129,"type":22},60,[131],"NA","Inflammatory Bowel Diseases (IBD) are chronic inflammations of the gastrointestinal tract. Regardless of the etiology, a common trait of IBD pathogenesis is the inflammatory damage inflicted on the intestinal mucosa and the loss of intestinal epithelial barrier integrity. Therefore, understanding the mechanisms that govern IEC's capacity to maintain barrier function and to orchestrate mucosal healing is considered a major goal in translational research. The investigators are interested in understanding how the inflammatory environment present in the intestinal mucosa, of IBD patients influences epithelial cells capacity to govern repair. The complexities of the cytokine and metabolic milieu present in IBD patients render the study of the contribution of each cytokine, metabolite, and intracellular pathway extremely complicated. Therefore, most of the processes that govern tissue regeneration are studied with the use of mouse models that recapitulate one or multiple features of IBD and allow for genetical modifications of the gene and pathway of interest. While mouse models are uniquely suited to study the complex crosstalk between the immune system, the microbiota, and the intestinal epithelia, they introduce the important problem of species-specific differences, which can hamper the translational value of mouse studies.\n\nTo overcome these shortcomings, the investigators propose to explore the influence of cytokines and metabolites in digestive organoids derived from patients and controls. Importantly, it was demonstrated that gene expression and innate immune responses are altered in primary organoids derived from patients with IBD, including altered ability to proliferate, respond to cytokines, metabolic capacity, and efficiently form organoids suggesting that major differences between patient's and control's epithelial cell biology can be faithfully replicated in this system.\n\nGiven these premises, the investigators propose the following objectives:\n\nPrimary objective:\n\nThe main objective of this study is to establish that patient's epithelial cells from inflamed mucosae have decreased ability to repair the intestinal mucosa, as compared to epithelial cells from non-inflamed regions in the same patient, or to control subject with no inflammatory digestive diseases.\n\nThe investigators will explore this question both deriving organoids from clinical samples and exposing them to pro inflammatory cytokines and metabolites in vitro, as well as by analyzing repair responses from the aforementioned clinical samples ex vivo.\n\nSecondary objective\n\nThe secondary goals of this study are:\n\n\\- To compare organoids derived from: epithelia in inflamed mucosa of IBD patients, epithelia in non-inflamed mucosa of IBD patients, and epithelia from the mucosa of non-IBD controls in their capacity to mount a repair response in response to inflammatory cytokines or luminal metabolites.\n\nNamely the investigators will evaluate the following parameters:\n\n* Their capacity to proliferate.\n* Their ability to survive treatment with pro-inflammatory cytokines\n* The activation of intracellular pathways associated with cell death.\n* Their overall metabolic activity.\n* The balance between stem and differentiated epithelial cell types.\n* The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival.\n* To evaluate hallmarks of tissue repair in biopsies derived from epithelia in inflamed mucosa of IBD patients, epithelia in non-inflamed mucosa of IBD patients, and epithelia from the mucosa of non-IBD controls, and to correlate them to the levels of inflammatory cytokines, luminal metabolites and overall disease severity. Namely the investigators will evaluate the following parameters:\n* The abundance of proliferating cells.\n* The activation of intracellular pathways associated with cell death and survival.\n* Their overall metabolic activity.\n* The balance between stem and differentiated epithelial cell types.\n* The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival.",[134,28,135],"Crohn Disease","Ulcerative Colitis (Disorder)","2025-08-21",{"date":138,"type":49},"2025-08-22",{"date":140,"type":49},"2025-07-24",{"date":142,"type":22},"2027-03-24",{"name":144,"class":56},"Assistance Publique Hopitaux De Marseille",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":18,"minAge":91,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":95,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":83},"100594640","evaluating-the-effectiveness-of-68ga-grazytracer-petct-in-inflammatory-bowel-disease-100594640","NCT07022080","Evaluating the Effectiveness of 68Ga-grazytracer PET\u002FCT in Inflammatory Bowel Disease","68Ga-grazytracer PET\u002FCT Study in Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Age between 18-80 years old; Clinical diagnosis of inflammatory bowel disease (active stage); Not having received treatment within 4 weeks prior to undergoing PET\u002FCT examination; Received endoscopy within 7 days before and after PET\u002FCT examination; Signing an informed consent form for PET\u002FCT examination and volunteering to participate in this study.\n\nExclusion Criteria:\n\n* No signed informed consent or unspecified diagnosis; Female subjects are pregnant or breastfeeding and male subjects are preparing for pregnancy; Those who are unfit to perform (concomitant severe and\u002For uncontrollable and\u002For unstable disease, developer allergy) or who are unable to complete imaging such as PET for specific reasons (needle-sickness, blood-sickness, claustrophobia); Colitis other than inflammatory bowel disease (infectious or ischaemic colitis); Patients who have undergone colon resection.","80 Years",{"count":154,"type":22},69,[131],"This is a single-centre, prospective, observational cohort study in which 69 patients with inflammatory bowel disease (IBD) were recruited to undergo 68Ga-grazytracer PET\u002FCT imaging in patients with IBD to investigate the feasibility of early sensitive detection or prediction of the response to medication in patients with inflammatory bowel disease on 68Ga-grazytracer PET\u002FCT and early prediction of the The feasibility of 68Ga-grazytracer PET\u002FCT for early detection or prediction of response to drug therapy and early prediction of long-term prognosis in patients with inflammatory bowel disease.",[28],[159,160],"PET\u002FCT","68Ga-grazytracer","2025-06-08",{"date":163,"type":49},"2025-06-15",{"date":163,"type":22},{"date":166,"type":22},"2027-12-31",{"name":168,"class":56},"Xijing Hospital"]