[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605809":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":74,"collaborators":78,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":25,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":25,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"The Affiliated Hospital of Qingdao University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Clostridium butyricum group","EXPERIMENTAL","Oral Clostridium butyricum capsules, Live: take 3 capsules twice daily (bid) for the first 3 months after adenoma resection, then continue with 3 capsules once daily (qd) until 3 years post-resection (each capsule contains ≥6.3 × 10⁶ CFU of Clostridium butyricum).",[13],"Drug: Clostridium butyricum capsules, Live",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the study group.",[19],"Other: Control (placebo)",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Clostridium butyricum capsules, Live",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Control (placebo)","Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.",[15],[31],{"name":32,"affiliation":5,"role":33},"yanbing Zhou","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Gan Liu","CONTACT","+86 18866799842","docliu163@163.com",{"name":32,"role":37,"phone":41,"phoneExt":25,"email":42},"+86 0532-82911324","zhouyanbing@qduhospital.cn",[44,61],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"the Affiliated Hospital of QIngdao University","RECRUITING","Qingdao","Shandong","266000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],120.38042,36.06488,{"lat":56,"lon":55},[59,60],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":32,"role":37,"phone":25,"phoneExt":25,"email":42},{"facility":62,"status":46,"city":63,"state":48,"zip":25,"country":50,"countryCode":51,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Weifang People's Hospital","Weifang",{"type":53,"coordinates":65},[66,67],119.10194,36.71,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":72,"phoneExt":25,"email":73},"Junxi Sun","13573667956","sjx1971@sina.com",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Zhou Yanbing","The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University",[79,81,83,85,87,88,90,92,94],{"name":80,"class":6},"Shandong Cancer Hospital and Institute",{"name":82,"class":6},"Yantai Yuhuangding Hospital",{"name":84,"class":6},"Rizhao People's Hospital",{"name":86,"class":6},"Qianfoshan Hospital",{"name":62,"class":6},{"name":89,"class":6},"Dongying People's Hospital",{"name":91,"class":6},"Peking University People's Hospital",{"name":93,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"name":95,"class":6},"The First Affiliated Hospital of Bengbu Medical University","100605809","phase-4-the-effect-of-oral-clostridium-butyricum-on-the-recurrence-after-colonoscopic-resection-of-colorectal-adenoma-100605809",false,"NCT07167342","The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma","The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma - A Multicenter, Double-blinded, Differential Design, Randomized, Placebo-controlled Study","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* No restriction on sex\n* Boston Bowel Preparation Score (BBPS) ≥ 7 prior to endoscopic procedure\n* Completed endoscopic resection of colorectal adenomas (including cold snare polypectomy, ESD, EMR, etc.) with no residual adenomas or polyps observed endoscopically\n* Histologically confirmed adenomas (including tubular, villous, or tubulovillous types) without malignant transformation\n* Able to take oral medication\n* Signed informed consent\n\nExclusion Criteria:\n\n* Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment\n* Presence of psychiatric disorders or other conditions preventing compliance with the intervention\n* Dysfunction of vital organs (liver, kidney, heart, etc.) deemed unsuitable for clinical study participation after evaluation\n* Participation in other clinical trials within 3 months prior to enrollment\n* History of gastrointestinal surgery (excluding endoscopic procedures)\n* History of inflammatory bowel disease\n* History of autoimmune diseases\n* Long-term use of aspirin (≥100 mg\u002Fday for over 3 months) or calcium supplements (≥1200 mg\u002Fday for over 3 months)\n* Pregnancy or breastfeeding\n* Previous treatment for colorectal adenomas (including endoscopic or surgical resection)\n* Familial adenomatous polyposis (FAP)","ALL","18 Years","75 Years",{"count":107,"type":108},294,"ESTIMATED","INTERVENTIONAL",[111],"PHASE4","The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. Therefore, this study, designed as a multicenter, double-blind, placebo-controlled randomized controlled trial, aims to explore evidence-based data on the role of Clostridium butyricum in preventing colorectal adenoma recurrence.",[114,115],"Colorectal Adenoma","Probiotics",[114,117],"Clostridium butyricum","2026-05-22",{"date":120,"type":121},"2026-05-26","ACTUAL",{"date":118,"type":121},{"date":124,"type":108},"2030-04-30",{"name":5,"class":6},2]