[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524282":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":16,"locations":26,"responsibleParty":45,"collaborators":7,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":7,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":7,"studyType":60,"phases":7,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"The Second Hospital of Nanjing Medical University","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"WMT","Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive one dose of WMT for CDI. During follow-up, those who have non-response or CDI recurrence within 4-week post-WMT will receive rescue WMT.",[13],{"name":14,"affiliation":5,"role":15},"Faming Zhang","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Faming Zhang, PhD","CONTACT","086-025-58509883","fzhang@njmu.edu.cn",{"name":23,"role":19,"phone":24,"phoneExt":7,"email":25},"Bota Cui","086-025-58509884","cuibota@njmu.edu.cn",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The second affiliated hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210011","China","CN",{"type":36,"coordinates":37},"Point",[38,39],118.77778,32.06167,{"lat":39,"lon":38},[42],{"name":43,"role":19,"phone":44,"phoneExt":7,"email":7},"Jie Zhang","58509931",{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100524282","washed-microbiota-transplantation-for-clostridioides-difficile-infection-100524282",false,"NCT06106698","Washed Microbiota Transplantation for Clostridioides Difficile Infection","Washed Microbiota Transplantation for Clostridioides Difficile Infection: a Real World Research","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to enter the study:\n\n1. At the time of informed consent, male or non-pregnant or non-lactating female.\n2. The diagnostic criteria for C. difficile infection are met during screening:\n\n   1. Medical records confirming CDI prior to screening (laboratory tests are positive for Clostridium difficile or its toxin): Clostridium difficile toxin test is positive (determined by EIisa test), or colonoscopy indicates pseudomembranous enteritis; Or Glutamate dehydrogenase positive, toxin negative, there are obvious causes and diarrhea.\n   2. CDI-related diarrhea episodes, i.e., defecation ≥3 times\u002Fday for at least two consecutive days with unformed stools (Bristol score 6-7).\n3. The subject or his\u002Fher legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria must be excluded from the study:\n\n1. Subjects with immune deficiencies (such as HIV infection, or neutrophils \\\u003C0.5×109\u002FL in absolute value, or lymphocytes \\\u003C0.5×109\u002FL, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g\u002Fd of prednisone or equal doses of steroid hormones).\n2. There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed.\n3. Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.\n4. Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening.\n5. At the time of screening, the subject or his\u002Fher legal representative refuses to take effective contraception within 3 months after the last treatment.\n6. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.","ALL","3 Years","100 Years",{"count":58,"type":59},100,"ESTIMATED","OBSERVATIONAL","This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation （WMT） for patients with Clostridioides Difficile Infection （CDI）.",[63],"Clostridioides Difficile Infection",[65,63,66,67],"washed microbiota transplantation","Intestinal infection","Antibiotic-associated Diarrhea","2023-10-24",{"date":70,"type":71},"2023-10-30","ACTUAL",{"date":73,"type":71},"2023-07-22",{"date":75,"type":59},"2029-12",{"name":5,"class":6},1]