[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100325395":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":28,"studyPopulation":21,"armGroups":29,"interventions":40,"overallOfficials":47,"centralContacts":51,"locations":56,"responsibleParty":74,"collaborators":77,"id":80,"slug":21,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":21,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":21,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":59,"whyStopped":21,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"The Second Hospital of Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical response rate","The clinical response rate at 8 weeks after fmt treatment","12 weeks",[14,18],{"measure":15,"description":16,"timeFrame":17},"Scores of gastrointestinal symptoms","Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0","4, 8, 12 weeks",{"measure":19,"description":20,"timeFrame":17},"Change of toxicity grade","The change of toxicity grade according to the RTOG\u002FEORTC toxicity scale at 4, 8, 12 weeks after FMT",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE","The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. At enrollment, \"Shared Decision Making\" intervention was applied to support patient involvement in making health decisions. Patients have opportunity to choose fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 12 weeks. Blood test, endoscopy and questionnaire will be used to access participants at study start and at study completion. Fecal microbiota compositions, blood and urinary metabolic profiles of patients will be analyzed to assess associated microbial changes.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Fecal Microbiota Transplantation (FMT)","EXPERIMENTAL","Patients receive a course of FMT during hospitalization",[35],"Procedure: Fecal Microbiota Transplantation (FMT)",{"label":37,"type":38,"description":39,"interventionNames":21},"Basic treatment","NO_INTERVENTION","Patient receives basic therapy for RE during hospitalization",[41],{"type":42,"name":31,"description":43,"armGroupLabels":44,"otherNames":45},"PROCEDURE","Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy or colonic TET tube",[31],[46],"FMT",[48],{"name":49,"affiliation":5,"role":50},"Faming Zhang, MD; PHD","PRINCIPAL_INVESTIGATOR",[52],{"name":49,"role":53,"phone":54,"phoneExt":21,"email":55},"CONTACT","086-25-58509883","fzhang@njmu.edu.cn",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210011","China","CN",{"type":66,"coordinates":67},"Point",[68,69],118.77778,32.06167,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":54,"phoneExt":21,"email":55},"Faming Zhang, MD, PhD",{"type":50,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Faming Zhang","Professor, Microbiota Medicine, Gastroenterology",[78],{"name":79,"class":6},"Jiangxi Provincial Cancer Hospital","100325395",false,"NCT03516461","Fecal Microbiota Transplantation for Radiation Enteritis","Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis","Inclusion Criteria:\n\n1. age ≥18 years old;\n2. Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.\n\nExclusion Criteria:\n\n1. Patients who were pregnant or nursing;\n2. Patients who were unable or unwilling to undergo a gastroscopy;\n3. Patients who had gastrointestinal infection;\n4. Patients with cardiopulmonary failure.","ALL","18 Years","85 Years",{"count":90,"type":91},70,"ESTIMATED","INTERVENTIONAL",[94],"NA","Radiation enteritis is one of the most feared complications after abdominal or pelvic radiation therapy.The gut microbiota is considered to constitute a \"microbial organ\" which has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for radiation enteritis.",[97],"Radiation Enteritis",[99,97,100],"Gut Microbiota","Fecal Microbiota Transplantation","2025-03-27",{"date":103,"type":104},"2025-03-30","ACTUAL",{"date":106,"type":104},"2018-01-07",{"date":108,"type":91},"2025-07-01",{"name":5,"class":6},1]