[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502965":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":46,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":19,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":19,"overallStatus":31,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Microbiota Transplant (FMT)","EXPERIMENTAL","Single arm of 16-18 subjects, all of whom will receive the interventional FMT.",[13],"Drug: Fecal Microbiota Transplant (FMT)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The intervention consists of the following steps:\n\n* Step 1: Vancomycin 125 mg orally every 6 hours and metronidazole 250 mg orally every 6 hours for 5 days.\n* Step 2: Bowel preparation with 10 ounces of magnesium citrate.\n* Step 3: Two FMT doses will be administered via enema one week apart using stool from donors with a durably healthy pouch.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Maia Kayal, MD, MS","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","212-241-0150","Maia.Kayal@mountsinai.org",[30],{"facility":5,"status":31,"city":32,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","New York","10029","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-74.00597,40.71427,{"lat":40,"lon":39},[43,44],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"name":45,"role":23,"phone":19,"phoneExt":19,"email":19},"Maia Kayal",{"type":47,"investigatorFullName":45,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Assistant Professor","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":59,"type":60},16,"ESTIMATED","INTERVENTIONAL",[63],"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.",[66,67],"Chronic Pouchitis","Pouchitis","2025-07-10",{"date":70,"type":71},"2025-07-15","ACTUAL",{"date":73,"type":71},"2024-09-01",{"date":75,"type":60},"2026-12",{"name":45,"class":6},1]