[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561503":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":24,"locations":29,"responsibleParty":42,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":24,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":24,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":75,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"First Affiliated Hospital of Kunming Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"the Bai nationality-UC","EXPERIMENTAL","Ulcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope",[13],"Procedure: Fecal microbiota transplantation",{"label":15,"type":10,"description":16,"interventionNames":17},"the Han nationality-UC","Ulcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Fecal microbiota transplantation","Transplantation of fresh fecal bacterial fluid into the ileocecum of patients with ulcerative colitis via the colonoscopic route",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"L Y Miao, Doctor","PRINCIPAL_INVESTIGATOR",[30],{"facility":31,"status":24,"city":32,"state":33,"zip":34,"country":31,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":24},"China","Kunming","Yunnan","650032","CN",{"type":37,"coordinates":38},"Point",[39,40],102.71833,25.03889,{"lat":40,"lon":39},{"type":28,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Yinglei Miao","Director",[46],{"name":47,"class":6},"Chinese University of Hong Kong","100561503","efficacy-and-mechanism-of-fecal-microbiota-transplantation-of-the-bai-ethnicity-in-the-treatment-of-uc-100561503",true,"NCT06591013","Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC","Research on the Mechanisms of Different Donors in Fecal Microbiota Transplantation for Treating Ulcerative Colitis","Inclusion Criteria:\n\n1. Age between 14 and 79 years (inclusive), any gender.\n2. Diagnosed with ulcerative colitis (UC) per established clinical, endoscopic, and histological standards, with a disease duration of over 3 months.\n3. Active mild-to-moderate UC, defined by a Mayo score of 4-10, including an endoscopic score ≥1 and a physician's global assessment score ≤2.\n4. Stable baseline medication consisting of 5-aminosalicylic acid (mesalamine).\n5. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Participants unable to provide informed consent, answer questionnaires, or supply samples.\n2. Pregnant women or those attempting to conceive.\n3. Participants unwilling to use effective contraception throughout the study.\n4. Participants deemed in remission by investigators.\n5. Evidence or history of toxic megacolon.\n6. Isolated rectal inflammation (\\\u003C5 cm in extent).\n7. Diagnosed with Crohn's disease or indeterminate colitis.\n8. Participants with perianal diseases (e.g., fistulae, anal fissures).\n9. History of significant gastrointestinal surgery (e.g., colectomy) ：\n\n   * Minor surgeries will be reviewed case by case.\n   * Patients with appendectomy within 3 months will be excluded.\n10. Antibiotic use within the past 4 weeks for any reason, including for UC.\n11. Steroid dependence requiring \\>20 mg prednisone or \\>9 mg budesonide daily at enrollment.\n12. Recent or anticipated usage of prohibited drugs during the study period, including:\n\n    * Rectal corticosteroids within 2 weeks prior to the first FMT.\n    * Biologics (e.g., infliximab, adalimumab, vedolizumab) within 4 weeks prior to the first FMT.\n    * Other major immunosuppressants (e.g., calcineurin inhibitors, antitumor drugs) within 12 weeks prior to treatment.\n    * Probiotics within 4 weeks before the first FMT.\n    * Experimental drugs or protocols within 12 weeks before the first FMT.\n    * Anti-tuberculosis (TB or MAC) treatment within 4 weeks before the first FMT.\n\nPermitted Medications:\n\nParticipants may continue using the following medications if doses are stable within specified timeframes before the first FMT:\n\n* Oral 5-aminosalicylic acid (stable for 4 weeks).\n* Azathioprine and methotrexate (≥90 days of use with stable doses for 4 weeks).\n* Oral prednisone (≤20 mg\u002Fday, stable for 2 weeks, gradually tapered at a rate of 2.5 mg\u002Fweek to discontinue by week 8).\n\nSubjects should maintain the same doses of oral 5-aminosalicylates, thiopurines, and methotrexate during the study. For oral prednisolone, the dose had to be tapered off gradually, at a rate of 2.5mg per week, so that subjects were no longer exposed to steroids until week 8.\n\nProhibited Medications:\n\n* Rectal corticosteroids (2 weeks before and throughout the study).\n* Antibiotics, antifungals, antivirals, probiotics, or prebiotics (4 weeks before and throughout the study).\n* Biologics or calcineurin inhibitors (12 weeks before and throughout the study). Participants using prohibited medications during the study will remain enrolled, and outcomes will still be evaluated. All prohibited medication usage will be recorded.",false,"ALL","14 Years","79 Years",{"count":60,"type":61},102,"ACTUAL","INTERVENTIONAL",[64],"NA","Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), affects over 2 million people worldwide . Although biological therapies have significantly improved the treatment outcomes for UC, nearly two-thirds of patients experience diminishing drug responses over time, making it crucial to explore novel therapeutic approaches targeting the underlying pathophysiology of UC. UC is associated with alterations in gut microbiota, reduced microbial diversity, and changes in the relative abundance of dominant bacterial populations. Specifically, UC patients exhibit a marked decrease in gut microbiota diversity at the species level, with a reduction in Firmicutes (e.g., Clostridium butyricum) and an increase in Actinobacteria, Proteobacteria (e.g., Escherichia coli), Enterobacteriaceae, Streptococcus, and Bacteroides . Given the association between gut microbiota alterations and IBD activity, several studies have proposed microbiota-based therapies, particularly fecal microbiota transplantation (FMT), as a treatment for UC.",[67],"Inflammatory Bowel Diseases",[69,70,71,72,73,74],"fecal microbiota transplantation（FMT）","the Bai Nationality of Yunnan","Intestinal flora","colonoscope","transendoscopic enteral tubing（TET）","ulcerative colitis","COMPLETED","2026-06-04",{"date":78,"type":61},"2026-06-30",{"date":80,"type":61},"2024-10-14",{"date":82,"type":61},"2025-10-31",{"name":5,"class":6},1]