[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601521":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":29,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":10},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"UC patients accept therapy of biologics",null,[12],"Diagnostic Test: fecal calprotectin",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DIAGNOSTIC_TEST","fecal calprotectin","patients will accpet test of FC combine FIT",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Yan Zhang, M.D","CONTACT","+86 18560089821","qlzhangyan@sdu.edu.cn",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","zhangyan","M.D",[30,32,34,36,38],{"name":31,"class":6},"Qilu Hospital of Shandong University (Qingdao)",{"name":33,"class":6},"Dezhou Hospital Qilu Hospital of Shandong University",{"name":35,"class":6},"Weihai Municipal Hospital",{"name":37,"class":6},"Liaocheng People's Hospital",{"name":39,"class":6},"Jining First People's Hospital","100601521","fecal-biomarker-response-evaluation-for-super-early-efficacy-in-ulcerative-colitis-100601521",false,"NCT07111572","Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis","Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study","FORESEE-UC","Inclusion Criteria:\\*\\*\n\n* Age 18-75 years, UC diagnosis with endoscopic Mayo score (MES) ≥2\n* Moderate-to-severe activity (Full Mayo Score ≥6)\n* Initiating vedolizumab or infliximab within 7 days after baseline\n* Biologic-naïve or prior exposure to only one TNF-α inhibitor\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Pregnancy\u002Flactation\n* Contraindications to biologics (e.g., active TB, severe infection)\n* Experimental drug use within 4 weeks prior to baseline","ALL","18 Years","75 Years",{"count":52,"type":53},100,"ESTIMATED","OBSERVATIONAL","This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at \\*\\*Week 2 and Week 4\\*\\* after initiating biologic therapy (vedolizumab or infliximab) can predict clinical response at \\*\\*Week 14\\*\\* and mucosal healing at \\*\\*Week 52\\*\\* in moderate-to-severe ulcerative colitis (UC) patients. Primary outcome: clinical remission rate at Week 14.",[57,58,59],"Ulcerative Colitis (UC)","Fecal Calprotetin","FIT",[61,16,59],"UC","NOT_YET_RECRUITING","2025-08-01",{"date":65,"type":66},"2025-08-08","ACTUAL",{"date":63,"type":53},{"date":69,"type":53},"2026-12-01",{"name":5,"class":6}]