[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552618":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":34,"locations":11,"responsibleParty":44,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":11},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal flora transplantation group","EXPERIMENTAL",null,[13],"Biological: fecal microbiota transplantation",{"label":15,"type":16,"description":11,"interventionNames":17},"Formulated probiotics group","ACTIVE_COMPARATOR",[18],"Dietary Supplement: Formulated probiotic supplements",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","fecal microbiota transplantation","During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration.",[9],[26],"FMT",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Formulated probiotic supplements","During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the control group receiving a standardized probiotic formula.",[15],[33],"probiotic",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Fan Liu, Doctor","CONTACT","01088326600","liufan92@pkuph.edu.cn",{"name":41,"role":37,"phone":42,"phoneExt":11,"email":43},"Chang Wang, Doctor","15210196608","wangchang@pkuph.edu.cn",{"type":45,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Fan Liu","100552618","fecal-microbiota-transplantation-in-the-treatment-of-major-lars-100552618",false,"NCT06475430","Fecal Microbiota Transplantation in the Treatment of Major LARS","Evaluation of the Effectiveness of Fecal Microbiota Transplantation in the Treatment of Patients With Severe Low Anterior Resection Syndrome (LARS)","FMT-LARS","Inclusion Criteria:\n\n\\- Age ≥ 18 years old, regardless of gender; Patients with rectal cancer who have undergone total mesorectal excision (TME) and sphincter-preserving surgery, and the postoperative period is more than 3 months; Patients with a LARS score of 21 to 42; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Expected survival period ≥ 1 year; Voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n\\- Patients with pre-operative symptoms of fecal and urinary incontinence; Patients who have undergone pelvic surgery or LAR due to non-cancerous reasons; Patients who have undergone pelvic radiotherapy; Patients with prophylactic ostomy; Patients who have used any antibiotic medication, probiotic products, or prebiotic products in the past 4 weeks; Patients who have regularly used laxatives in the past two weeks; Pregnant or lactating women; Human immunodeficiency virus (HIV) positive; Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB require chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs; Untreated patients with chronic hepatitis B or HBV carriers with HBV DNA exceeding 500 IU\u002FmL, or patients with active hepatitis C should be excluded. Non-active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL), and cured hepatitis C patients can be enrolled. For subjects with positive HCV antibodies, only those with negative HCV RNA test results are eligible to participate in the study; Known history of psychiatric drug abuse, alcoholism, and drug abuse; Patients with cognitive impairment; Any situation where the investigator believes the participant should be excluded from the study.","ALL","18 Years","80 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"NA","Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.",[66,67],"Low Anterior Resection Syndrome","Fecal Microbiota Transplantation",[69,70,22,71],"low anterior resection syndrome","bowel function","intestinal microbiota","NOT_YET_RECRUITING","2024-06-20",{"date":75,"type":76},"2024-06-26","ACTUAL",{"date":78,"type":60},"2025-01-01",{"date":80,"type":60},"2026-12-31",{"name":5,"class":6}]