[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463980":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":37,"studyPopulation":34,"armGroups":38,"interventions":45,"overallOfficials":52,"centralContacts":56,"locations":64,"responsibleParty":83,"collaborators":34,"id":87,"slug":34,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":34,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":66,"whyStopped":34,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Tongji Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":24},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Clinical remission","Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10","8-12 weeks after FMT",{"measure":14,"description":15,"timeFrame":12},"Endoscopic remission","Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2",{"measure":17,"description":18,"timeFrame":12},"Mucosal healing","Mucosal healing defined as SES-CD = 0",[20],{"measure":21,"description":22,"timeFrame":23},"Adverse events","All possible adverse events:fever,abdominal pain,infectious diseases and others","2 and 8 weeks after FMT",[25],{"measure":26,"description":27,"timeFrame":28},"gut microbial","Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.","before treatment and 4-8 weeks after treatment",{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":34,"timePerspective":34,"maskingInfo":35},"NA","SINGLE_GROUP","Partial enteral nutrition,FMT","TREATMENT",null,{"masking":36,"maskingDescription":34,"whoMasked":34},"NONE","Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"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",[44],"Other: Standardized FMT",[46],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Standardized FMT","Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon",[40],[51],"Fecal Microbiota Transplantation",[53],{"name":54,"affiliation":5,"role":55},"Sainan Shu, MD, PhD","STUDY_DIRECTOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":34,"email":61},"Biao Zou, doctor","CONTACT","027-83663594","464021552@qq.com",{"name":54,"role":59,"phone":60,"phoneExt":34,"email":63},"shusainan@163.com",[65],{"facility":5,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":73,"coordinates":74},"Point",[75,76],114.26667,30.58333,{"lat":76,"lon":75},[79,81],{"name":58,"role":59,"phone":80,"phoneExt":34,"email":61},"15871365900",{"name":82,"role":59,"phone":60,"phoneExt":34,"email":63},"Sainan Shu, PhD",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Biao Zou","attending physician","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":98,"type":99},40,"ESTIMATED","INTERVENTIONAL",[30],"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",[104],"Crohn Disease",[106],"fecal microbiota transplantation , Crohn Disease","2024-11-01",{"date":109,"type":110},"2024-11-04","ACTUAL",{"date":112,"type":110},"2022-03-22",{"date":114,"type":99},"2026-05-31",{"name":85,"class":6},1]