[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463981":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":68,"collaborators":43,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":27,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":43,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":51,"whyStopped":43,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FMT group","ACTIVE_COMPARATOR","Repeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.",[13],"Biological: Fecal Microbiota Transplantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Immunosuppressive group","SHAM_COMPARATOR","Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment.",[19],"Drug: Immunosuppressive Agents",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Fecal Microbiota Transplantation","In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.",[9],[27],"FMT",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Immunosuppressive Agents","hormones, azathioprine, thalidomide",[15],[15],[35],{"name":36,"affiliation":5,"role":37},"Zhihua Huang","STUDY_DIRECTOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Biao Zou, MD","CONTACT","15871365900",null,"464021552@qq.com",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Sainan Shu, MD, PhD","13886011908","shusainan@163.com",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":58,"coordinates":59},"Point",[60,61],114.26667,30.58333,{"lat":61,"lon":60},[64,66],{"name":65,"role":41,"phone":42,"phoneExt":43,"email":44},"Biao Zou",{"name":67,"role":41,"phone":47,"phoneExt":43,"email":48},"Sainan Shu",{"type":69,"investigatorFullName":65,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","attending physician","100463981","fecal-microbiota-transplantation-as-the-first-line-treatment-in-active-pediatric-crohns-disease-100463981",false,"NCT05321758","Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease","Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease","Inclusion Criteria:\n\nage of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of \\>10 and ≤40, and SES-CD of \\>3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy\n\nExclusion Criteria:\n\npatients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment",true,"ALL","2 Years","16 Years",{"count":83,"type":84},50,"ESTIMATED","INTERVENTIONAL",[87],"NA","To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.",[90],"Crohn Disease",[92],"Crohn Disease;fecal microbiota transplantation","2026-07-09",{"date":95,"type":96},"2026-07-10","ACTUAL",{"date":98,"type":96},"2020-03-22",{"date":100,"type":84},"2027-06-30",{"name":5,"class":6},1]