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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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