[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625058":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":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":11},{"fullName":5,"class":6},"Chinese Medical Association","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Palmitoleic Acid + Infliximab","EXPERIMENTAL",null,[13],"Drug: Palmitoleic Acid + Infliximab",{"label":15,"type":16,"description":11,"interventionNames":17},"Infliximab alone","ACTIVE_COMPARATOR",[18],"Drug: Infliximab",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Patients will be administered oral palmitoleic acid at a dose of 720 mg once daily for 26 consecutive weeks, starting at Week 0.\n\nConcurrent infliximab will be administered intravenously at the standard dose of 5 mg\u002Fkg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"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":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","100625058","phase-4-palmitoleic-acid-combined-with-infliximab-for-promoting-intestinal-mucosal-healing-in-crohns-disease-100625058",false,"NCT07417696","Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease","A Randomized, Controlled Trial Investigating the Efficacy of Palmitoleic Acid 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. Established diagnosis of Crohn's disease confirmed by radiologic, histologic, 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 supplements containing fish oil or other lipid supplements (e.g., macadamia oil, krill oil, flaxseed, primrose oil, sea buckthorn oil) within 8 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.\n7. Known hypersensitivity to infliximab or palmitoleic acid preparations.","ALL","18 Years","75 Years",{"count":51,"type":52},400,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","This study aims to evaluate whether the combination of palmitoleic acid with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.",[58],"Crohn's Disease",[25,60,61,62],"Palmitoleic acid","Mucosal healing","Inflammatory bowel disease","NOT_YET_RECRUITING","2026-02-11",{"date":66,"type":67},"2026-02-18","ACTUAL",{"date":69,"type":52},"2026-04-01",{"date":71,"type":52},"2029-03-31",{"name":5,"class":6}]