Clinical Trial

Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis

Study acronym: FORESEE-UC
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 28, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-29
Trial Details
NCT Number NCT07111572
Lead Sponsor Qilu Hospital of Shandong University
Collaborators: Qilu Hospital of Shandong University (Qingdao), Dezhou Hospital Qilu Hospital of Shandong University, Weihai Municipal Hospital, Liaocheng People's Hospital, Jining First People's Hospital
Conditions Ulcerative Colitis (UC), Fecal Calprotetin, FIT
Enrollment 100 participants
Start Date 2025-08-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-28