[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"indeterminate-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:indeterminate-colitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,82,116,146,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100611202","zymfentra-infliximab-dyyb-real-world-cohort-study-100611202",false,"NCT07237516","Zymfentra (Infliximab-dyyb) REal World Cohort STudy","ZEST","Inclusion Criteria:\n\n\\- 1. Adult patients, age 18 years or older, with Crohn's disease (CD), ulcerative colitis (UC) or Inflammatory Bowel Disease Unclassified (IBDU), who are either starting Zymfentra at week 10 (IFX-dyyb) in the setting of standard-of-care initiation with intravenous Infliximab (IFX) originator or IFX biosimilars induction therapy at weeks 0,2,6 or switching from intravenous IFX originator or IFX biosimilars during maintenance therapy to Zymfentra (IFX-dyyb) 2. Anticipation that the patient will be followed by the participating center for the next 12 months.\n\n3\\. Diagnosis of CD, UC or IBDU must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.\n\nThe following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with CD, UC or IBDU:\n\nA) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, complicated perianal disease, extraintestinal manifestations, weight loss or failure to thrive.\n\nAND B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. When there has been a single episode of colitis (in some instances less than 6 weeks duration) resulting in colectomy and resolution of disease symptoms, pathology on the colectomy specimen should be consistent with idiopathic IBD and microbiology studies should be negative.\n\nAND\n\nC) One or more of the following providing objective evidence of inflammation:\n\nEndoscopic: Mucosal edema, erythema, loss of normal submucosal vasculature, friability, ulceration, stricture formation, pseudopolyps, mucosal edema, erythema. Where there are only minor changes (mucosal edema, erythema, loss of normal submucosal vasculature, friability) mucosal biopsies should have been done to confirm the presence of IBD.\n\nRadiologic: Mucosal thickening and\u002For nodularity, ulceration, stricture, pseudopolyps, fistula formation, pseudosacculation. Minor changes alone (mucosal thickening and\u002For nodularity) should not be sufficient to make a diagnosis of IBD.\n\nHistologic: Mucosal erosion or ulceration, architectural changes of crypts, Paneth cell metaplasia (in colon), transmural inflammatory infiltrate\\*, fibrosis of muscularis propria\\*, noncaseating granuloma\\*.\n\n\\* CD\n\nIndividuals with IBD should be classified into one of three categories, based on most recent diagnosis:\n\nCrohn's disease (CD):\n\n1. Evidence of small intestinal inflammation with endoscopically, radiologically or histologically demonstrated ulcerations, fistulation, mucosal fissuring, nodularity or cobblestoning, stricture formation or histologically demonstrated transmural inflammation with or without granuloma formation.\n2. Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.\n3. Colonic inflammation which is patchy (normal segments separating areas of inflammation, as described above) or associated with one or more of the following features: complete rectal sparing, multiple (\\>10) aphthoid ulcers, deep ulceration (into the muscularis propria), transmural inflammation, extensive fibrosis and wall thickening, fistulation, non-caseating granuloma. (N.B. See note below regarding patchiness of endoscopically observed inflammation in patients with partially treated ulcerative colitis.)\n4. The presence of complex suppurative perianal disease (i.e. more than a superficial fistula or uncomplicated superficial abscess).\n5. If there are fewer than 10 aphthoid ulcers in the cecum (and the rest of the colon appears normal) in a patient with small bowel disease then this should be called small bowel disease only. Similarly, if the colon is normal except for the presence of a fistula extending from inflamed small bowel, the patient should be said to have small bowel disease alone. If the cecum is involved with ulcers larger than aphthoid ulcers or ulcers that are deep or if the involvement has resulted in deformity of the cecum this would be considered to be colonic involvement.\n\nUlcerative Colitis (UC)\n\n1\\) Superficial inflammation and\u002For ulceration (involving only the mucosa and submucosa) of the colon which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (N.B. Relative rectal sparing is allowed for patients receiving topical rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).\n\n2\\) In patients with proctitis or left-sided ulcerative colitis there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.\n\n3\\) No inflammation of the small intestine (\"backwash ileitis\" is allowed - non-stricturing superficial inflammation of the terminal ileal mucosa associated with severe pancolitis which resolves following medical or surgical treatment of the colitis).\n\n4\\) No features of Crohn's disease listed above.\n\nInflammatory Bowel Disease Unclassified (IBDU):\n\n1. Confirmed IBD by A, B and C above.\n2. Physician unable to classify individual into either CD or UC based on above criteria and\u002For patient has features of both CD and UC with none of the feature's diagnostic of one or the other.\n\nExclusion Criteria:\n\n* 1\\.\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Inability to provide informed consent.\n2. Non-English speaking\n3. Patients presenting for a one-time consultation.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","12 Months","OBSERVATIONAL","The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.",[25,26,27,28],"Ulcerative Colitis (UC)","Crohn's Disease (CD)","Indeterminate Colitis","Inflammatory Bowel Disease (IBD)",[30,14],"Zymfentra","RECRUITING","2026-05-22",{"date":34,"type":35},"2026-05-26","ACTUAL",{"date":37,"type":35},"2025-11-20",{"date":39,"type":20},"2028-11-03",{"name":41,"class":42},"University of North Carolina, Chapel Hill","OTHER",9,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":55,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":69,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100540310","seattle-spatial-transcriptomic-research-in-inflammatory-bowel-disease-evaluation-stride-100540310","NCT06315179","Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)","Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation","STRIDE","Inclusion Criteria:\n\n* Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)\n\nExclusion Criteria:\n\n* Evidence of Other Complicating Medical Issues:\n* Other serious medical conditions, such as neurological, liver, kidney, or systemic disease\n* Pregnancy\n* Tobacco, alcohol, or illicit drug abuse","6 Years","21 Years",{"count":19,"type":20},"3 Years","This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.",[58,59,60,27,61,62,63,64,65,66,67,68],"Inflammatory Bowel Diseases","Crohn Disease","Ulcerative Colitis","Functional Abdominal Pain Syndrome","Functional Bowel Disorder","Esophageal Diseases","Gastroduodenal Disorder","Bowel Dysfunction","Gallbladder Diseases","Sphincter of Oddi Dysfunction","Anorectal Disorder",[70,71],"IBD","DGBI","2026-04-21",{"date":74,"type":35},"2026-04-24",{"date":76,"type":35},"2024-05-10",{"date":78,"type":20},"2030-01",{"name":80,"class":42},"Seattle Children's Hospital",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":22,"phases":4,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":81},"100617501","cedur---german-ibd-registry-100617501","NCT07319442","CEDUR - German IBD Registry","Long-term Observation of IBD Patients, a Nationwide German IBD Registry \"CEDUR\"","CEDUR","Inclusion Criteria:\n\n* Crohn Disease Ulcerative Colitis Indterminate Colitis\n\nExclusion Criteria:\n\n* Other gastrointestinal disorders than above",{"count":91,"type":20},10000,"10 Years","The CEDUR registry systematically collects real-world data on inflammatory bowel disease (IBD) patients in Germany. The registry aims to assess quality of care, disease activity, treatment effectiveness, safety, and pharmacoeconomic aspects under routine clinical conditions.",[25,27,95],"Crohn Disease (CD)",[70,97,98,60,99,100,101,102,103,104,105,106],"Registry","Crohn's disease","Real-world-data","Germany","Quality of care","pharmaeconomics","safety","long-term follow-up","patient journey","treatment algorithm","2025-12-21",{"date":109,"type":35},"2026-01-06",{"date":111,"type":35},"2018-05-03",{"date":113,"type":20},"2036-05",{"name":115,"class":42},"ImmunoRegister gUG",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":81},"100607943","evaluation-of-the-smart-ibd-app-in-pediatric-ibd-100607943","NCT07195123","Evaluation of the SMART IBD App in Pediatric IBD","Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)\n* Prescribed at least one daily or weekly medication for treatment of IBD\n* \\\u003C86% adherence to prescribed medication\n* Access to internet via Wi-Fi or data plan and access to smartphone\n* English fluency for patient and caregiver\n\nExclusion Criteria:\n\n* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review\n* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review","13 Years","17 Years",{"count":126,"type":20},70,"INTERVENTIONAL",[129],"NA","The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.",[28,132,133,25,27,95,70],"IBD (Inflammatory Bowel Disease)","IBD - Inflammatory Bowel Disease",[70,135,60,27,136],"Inflammatory Bowel Disease","Crohns Disease","2025-11-19",{"date":139,"type":35},"2025-11-21",{"date":141,"type":35},"2025-10-23",{"date":143,"type":20},"2027-08-31",{"name":145,"class":42},"Children's Hospital Medical Center, Cincinnati",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":154,"sex":16,"minAge":155,"maxAge":4,"enrollmentInfo":156,"targetDuration":92,"studyType":22,"phases":4,"briefSummary":158,"conditions":159,"keywords":170,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":81},"100566456","family-members-at-increased-risk-for-developing-inflammatory-bowel-disease-100566456","NCT06655415","Family Members At INcreased-risk for Developing Inflammatory Bowel Disease","Family Members At INcreased-risk for Developing Inflammatory Bowel Disease (FIND-IBD)","FIND-IBD","Inclusion Criteria:\n\n* Ability to give informed consent\n* Ability to complete all study visits and study-related procedures\n* Ability to understand and complete study questionnaires\n* Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or IBD-unclassified)\n* Age ≥ 14\n\nExclusion Criteria:\n\n* Individuals with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or IBD-unclassified)\n* Evidence of clinical signs or symptoms of IBD, which will be identified on pre-screening interview with the study coordinator.",true,"14 Years",{"count":157,"type":20},50,"First-degree relatives of people with inflammatory bowel disease (\"IBD,\" including Crohn's disease and ulcerative colitis) have an increased risk for developing IBD themselves. This study will follow unaffected first-degree relatives (who do not have IBD) over time to understand if their behaviors, diet, and biomarkers for IBD can help predict who gets IBD and if IBD can be prevented in these high-risk individuals. Participants will be asked once per year to complete a questionnaire and have their blood, stool, and urine collected. The anticipated length of the study (registry) is approximately 10 years or longer. Parts of this study, such as the questionnaires and stool and urine collection, may be done from home, while other parts, such as the blood draw, will need to be done from Massachusetts General Hospital.",[28,25,160,27,161,162,163,164,165,166,167,168,169],"IBD-unclassified (IBD-U)","Crohn's Disease Colon","Crohn's Colitis","Crohn's Ileocolitis","Crohn's Gastritis","Crohn's Jejunitis","Crohn's Duodenitis","Crohn's Esophagitis","Ulcerative Proctitis","Ulcerative Proctosigmoiditis",[135,70,171,98],"Ulcerative colitis","2024-12-18",{"date":174,"type":35},"2024-12-20",{"date":172,"type":35},{"date":177,"type":20},"2034-12",{"name":179,"class":42},"Massachusetts General Hospital",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":81},"100493381","digestive-biobank-for-exploring-microbiota-host-interactions-100493381","NCT05704413","Digestive Biobank for Exploring Microbiota-host Interactions","BiomHost","Inclusion Criteria:\n\n* Ulcerative colitis, Crohn's disease or colorectal disease\n* Digestive resection with useless tissue available\n* Information consent signed\n\nExclusion Criteria:\n\n\\- Patients \\\u003C 18 years",{"count":188,"type":20},500,"Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.",[58,59,60,191,27],"Colorectal Cancer",[193,194,98,195,196,197,198,199],"Microbiota","inflammatory bowel disease","ulcerative colitis","colorectal cancer","post-operative cognitive disorders","mood disorders","immune system.","2023-01-19",{"date":202,"type":35},"2023-01-30",{"date":204,"type":35},"2021-06-17",{"date":206,"type":20},"2026-09-17",{"name":208,"class":42},"Assistance Publique - Hôpitaux de Paris"]