[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491476":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":51,"collaborators":19,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":19,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FMT group","EXPERIMENTAL","In the refractory ulcerative colitis group, our study is aims to explore repeated and multiple FMTs plus PEN in the treatment of refractory pediatric UC;",[13],"Other: Fecal Microbiota Transplantation",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Fecal Microbiota Transplantation","In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT group are given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Zhihua Huang","STUDY_DIRECTOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Biao Zou","CONTACT","+8685726753","464021552@qq.com",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":32},"Sainan Shu, MD, PhD","shusainan@163.com",[34],{"facility":5,"status":35,"city":36,"state":19,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Wuhan","430030","China","CN",{"type":41,"coordinates":42},"Point",[43,44],114.26667,30.58333,{"lat":44,"lon":43},[47,50],{"name":48,"role":27,"phone":49,"phoneExt":19,"email":32},"Sainan Shu, professor","13886011908",{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},{"type":52,"investigatorFullName":26,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","attending physician, Pediatric Department","100491476","fecal-microbiota-transplantation-in-pediatric-ulcerative-colitis-uc-100491476",false,"NCT05679622","Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)","Repeated and Multiple Fecal Microbiota Transplantations in Active Pediatric Ulcerative Colitis (UC)","FMT","Inclusion Criteria:\n\nage of older than 2 years and younger than 16 years with no genetic diseases; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of \\>10 and≤64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of \\>10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy\n\nExclusion Criteria:\n\nChildren who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; Unwilling to give informed consent\u002F assent",true,"ALL","2 Years","16 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"NA","This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC",[74],"Ulcerative Colitis",[76],"Fecal microbiota transplantation, Ulcerative Colitis","2024-11-01",{"date":79,"type":80},"2024-11-04","ACTUAL",{"date":82,"type":80},"2022-12-01",{"date":84,"type":68},"2025-06-30",{"name":26,"class":6},1]