[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-pouchitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-pouchitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100502965","early-phase-1-fecal-microbiota-transplant-for-patients-with-chronic-pouchitis-100502965",false,"NCT05829109","Fecal Microbiota Transplant for Patients With Chronic Pouchitis","Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation","Inclusion Criteria:\n\nPatients age 18 or greater with UC who have undergone TPC with IPAA and have one of the following chronic pouchitis phenotypes, each defined as:\n\n* Chronic antibiotic dependent pouchitis:\n* The need for continuous antibiotic therapy (\\>4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to stop antibiotic therapy resulting in pouchitis episodes, OR\n* Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and a history of ≥4 antibiotic therapies in the last 12 months\n* Chronic antibiotic refractory pouchitis:\n* Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 with no response to antibiotics\n* Crohn's disease like pouch inflammation on biologic or small molecule therapy with persistent symptoms:\n* Pre-pouch ileal inflammation, strictures, and\u002For fistulae, AND\n* Active biologic or small molecule therapy, AND\n* Persistent symptoms with mPDAI clinical sub-score ≥ 2\n\nExclusion Criteria:\n\nPatients with UC who underwent TPC with IPAA and meet one of the following criteria will be excluded:\n\n* Allergy to vancomycin, metronidazole, or ingredients present in the FMT\n* Women who are breastfeeding\n* Women who are pregnant\n* Participants with fever \\> 100.4F\u002F38C or other signs of active illness\n* Active treatment with biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab)\n* Active treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), steroids or any investigational drugs\n* Crohn's disease like pouch inflammation\n* Active enteric infection\n* Isolated cuffitis\n* Clinically significant strictures of the pouch inlet or outlet\n* Participation in a clinical trial in the preceding 30 days\n* Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines will put the participant at greater risk from FMT","ALL","18 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.",[26,27],"Chronic Pouchitis","Pouchitis","RECRUITING","2025-07-10",{"date":31,"type":32},"2025-07-15","ACTUAL",{"date":34,"type":32},"2024-09-01",{"date":36,"type":20},"2026-12",{"name":38,"class":39},"Maia Kayal","OTHER"]