[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463980":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":53,"collaborators":30,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":30,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":36,"whyStopped":30,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Repeated and multiple FMTs plus PEN","EXPERIMENTAL","repeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD",[13],"Other: Standardized FMT",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Standardized FMT","Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon",[9],[20],"Fecal Microbiota Transplantation",[22],{"name":23,"affiliation":5,"role":24},"Sainan Shu, MD, PhD","STUDY_DIRECTOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Biao Zou, doctor","CONTACT","027-83663594",null,"464021552@qq.com",{"name":23,"role":28,"phone":29,"phoneExt":30,"email":33},"shusainan@163.com",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":43,"coordinates":44},"Point",[45,46],114.26667,30.58333,{"lat":46,"lon":45},[49,51],{"name":27,"role":28,"phone":50,"phoneExt":30,"email":31},"15871365900",{"name":52,"role":28,"phone":29,"phoneExt":30,"email":33},"Sainan Shu, PhD",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Biao Zou","attending physician","100463980","fecal-microbiota-transplantation-in-pediatric-crohns-disease-100463980",false,"NCT05321745","Fecal Microbiota Transplantation in Pediatric Crohn's Disease","Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease","FMT","Inclusion Criteria:\n\nAged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) \\>10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) \\> 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics)\n\nExclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; 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\u002Fassent","ALL","2 Years","16 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment",[76],"Crohn Disease",[78],"fecal microbiota transplantation , Crohn Disease","2024-11-01",{"date":81,"type":82},"2024-11-04","ACTUAL",{"date":84,"type":82},"2022-03-22",{"date":86,"type":70},"2026-05-31",{"name":55,"class":6},1]