DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis

This multicenter prospective cohort study aims to evaluate whether a \>50% decrease or normalization of both quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC) levels at 2 weeks after starting conventional therapy (mesalazine or corticosteroids) can predict clinical relapse or need for biologic/JAK inhibitor therapy escalation by 52 weeks in biologic-naive patients with active ulcerative colitis (UC). Secondary objectives include assessing predictive value at 4 weeks, building dynamic prediction models, conducting health economic evaluation (Number Needed to Test, NNT), and exploring baseline predictors of early biomarker response. Patients will be observed during standard care with stool samples collected at Weeks 0, 2, and 4. Biomarker results will be blinded to clinicians/patients until study completion.

NCT Number	NCT07111273
Lead Sponsor	Qilu Hospital of Shandong University Collaborators: Qilu Hospital of Shandong University (Qingdao), Dezhou Hospital Qilu Hospital of Shandong University, JiNing NO.1 People Hospital, Zaozhuang Municipal Hospital, caoxian chinese medicine hospital, longkou chinsese medicine hospital, Shouguang people's Hospital, Weihai Municipal Hospital, Liaocheng People's Hospital, ZhangQiu Yile Hospital
Conditions	Ulcerative Colitis (UC), Fecal Calprotetin, FIT, Biomarker
Enrollment	100 participants
Start Date	2025-08-01
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-28