Not Yet RecruitingNot Applicable

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

100 participantsStarted 2025-08-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:\*\* * Age 18-75 years, UC diagnosis with endoscopic Mayo score (MES) ≥2 * Moderate-to-severe activity (Full Mayo Score ≥6) * Initiating vedolizumab or infliximab within 7 days after baseline * Biologic-naïve or prior exposure to only one TNF-α inhibitor \*\*Exclusion Criteria:\*\* * Pregnancy/lactation * Contraindications to biologics (e.g., active TB, severe infection) * Experimental drug use within 4 weeks prior to baseline

What they're measuring

Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14**

Timeframe: WEEK 14

Trial details

NCT IDNCT07111572

SponsorQilu Hospital of Shandong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-01

Contact for this trial

Yan Zhang, M.D

+86 18560089821 qlzhangyan@sdu.edu.cn

View on ClinicalTrials.gov More Ulcerative Colitis (UC) trials