[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624887":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":28,"collaborators":32,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":11,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":11},{"fullName":5,"class":6},"Chinese Medical Association","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Akkermansia muciniphila + Infliximab","EXPERIMENTAL",null,[13],"Drug: Akkermansia muciniphila + Infliximab",{"label":15,"type":16,"description":11,"interventionNames":17},"Infliximab alone","ACTIVE_COMPARATOR",[18],"Drug: Infliximab",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Infliximab","Patients will receive infliximab alone administered intravenously at the standard dose of 5 mg\u002Fkg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.",[15],{"type":21,"name":9,"description":26,"armGroupLabels":27,"otherNames":11},"Patients will receive oral Akkermansia muciniphila once daily starting at Week 0. Concurrently, they will receive intravenous infliximab at the standard dose of 5 mg\u002Fkg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.",[9],{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Sheng-hong Zhang","Chief Physician, Professor",[33,36,38],{"name":34,"class":35},"First Affiliated Hospital, Sun Yat-Sen University","OTHER",{"name":37,"class":35},"Sixth Affiliated Hospital, Sun Yat-sen University",{"name":39,"class":35},"Shenzhen University General Hospital","100624887","phase-4-akkermansia-muciniphila-combined-with-infliximab-for-promoting-intestinal-mucosal-healing-in-crohns-disease-100624887",false,"NCT07415473","Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease","A Randomized, Controlled Trial Investigating the Efficacy of Akkermansia Muciniphila Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease","Inclusion Criteria:\n\n1. Adult patients aged 18 to 75 years.\n2. Documented diagnosis of Crohn's disease established at any time prior to screening by radiological, histological, or endoscopic evidence.\n3. Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive).\n4. Adequate cardiac, renal and hepatic function, as assessed by the investigator based on screening laboratory tests, physical examination, and medical history, without findings that would pose an undue risk for study participation.\n5. Willingness and ability to provide written informed consent.\n6. Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations.\n\nExclusion Criteria:\n\n1. Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening.\n2. Use of systemic antibiotics or any probiotic preparation within 4 weeks prior to screening.\n3. History of any intestinal resection or other Crohn's disease-related surgery.\n4. History of or active chronic or recurrent infectious disease.\n5. History of or current malignancy.\n6. Pregnancy, lactation, or intention to become pregnant during the study period.","ALL","18 Years","75 Years",{"count":51,"type":52},400,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","This study aims to evaluate whether the combination of Akkermansia muciniphila with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.",[58],"Crohn's Diseases",[60,22,61,62,63],"Mucosal healing","Akkermansia muciniphila","Probiotics","Inflammatory bowel disease","NOT_YET_RECRUITING","2026-02-10",{"date":67,"type":68},"2026-02-17","ACTUAL",{"date":70,"type":52},"2026-04-01",{"date":72,"type":52},"2029-03-31",{"name":5,"class":6}]