[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604697":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":56,"collaborators":59,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":26,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":109,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"The Affiliated Hospital of Qingdao University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention group","EXPERIMENTAL","Oral administration of Clostridium butyricum capsules during adjuvant chemotherapy, 6 capsules tid. (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).",[13],"Drug: Clostridium butyricum capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","PLACEBO_COMPARATOR","Oral administration of placebo capsules, 6 capsules three times daily, containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group.",[19],"Other: placebo capsules",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Clostridium butyricum capsules","Clostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"placebo capsules","Oral administration of placebo capsules, 6 capsules tid., containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group.",[15],[32],{"name":33,"affiliation":5,"role":34},"Yanbing Zhou","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Gan Liu","CONTACT","18866799842","docliu163@163.com",[42],{"facility":5,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Qingdao","Shandong","266071","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.38042,36.06488,{"lat":52,"lon":51},[55],{"name":37,"role":38,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Zhou Yanbing","The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University",[60,63,65,67,69,71,73,75,77,79,81,84],{"name":61,"class":62},"Shandong Provincial Hospital","OTHER_GOV",{"name":64,"class":6},"Linyi People's Hospital",{"name":66,"class":6},"Shandong Cancer Hospital and Institute",{"name":68,"class":6},"Yantai Yuhuangding Hospital",{"name":70,"class":6},"Jining First People's Hospital",{"name":72,"class":6},"Rizhao People's Hospital",{"name":74,"class":6},"Qianfoshan Hospital",{"name":76,"class":6},"Weifang People's Hospital",{"name":78,"class":6},"Qilu Hospital of Shandong University",{"name":80,"class":6},"Taian City Central Hospital",{"name":82,"class":83},"The Affiliated Hospital of Shandong Second Medical University","UNKNOWN",{"name":85,"class":6},"Dongying People's Hospital","100604697","phase-4-the-effects-of-clostridium-butyricum-on-adverse-events-during-adjuvant-chemotherapy-for-colorectal-cancer-100604697",false,"NCT07152886","The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer","The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Aged 18-70 years;\n* No restriction on gender;\n* Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens (including chemotherapy, targeted therapy, or radiotherapy);\n* ECOG performance status score of 0-2;\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 that prevent cooperation with the intervention;\n* Dysfunction of vital organs such as the liver, kidneys, or heart that renders the individual unsuitable for clinical research upon assessment, or inadequate bone marrow, liver, or renal function to undergo adjuvant therapy;\n* Participation in other clinical studies within 3 months prior to enrollment;\n* History of inflammatory bowel disease;\n* History of autoimmune diseases;\n* Pregnancy or breastfeeding;\n* Receipt of neoadjuvant therapy (including chemotherapy, radiotherapy, or targeted therapy) prior to surgery;\n* Underwent ostomy surgery during the operation (including temporary or permanent ostomy).","ALL","18 Years","70 Years",{"count":97,"type":98},238,"ESTIMATED","INTERVENTIONAL",[101],"PHASE4","This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.",[104,105],"Colorectal Cancer","Chemotherapeutic Toxicity",[104,107,108],"adjuvant chemotherapy","Clostridium butyricum","NOT_YET_RECRUITING","2025-08-26",{"date":112,"type":113},"2025-09-03","ACTUAL",{"date":115,"type":98},"2025-10-31",{"date":117,"type":98},"2027-12-31",{"name":5,"class":6},1]