Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis (NCT07111572) | Clinical Trial Compass
RecruitingNot Applicable
Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
China100 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.
1This trial is measuring fecal biomarkers like fecal calprotectin and FIT as early signs of whether a treatment is working — can you explain what those markers are and whether tracking them would give us useful information about my UC even outside of a trial?
2The trial isn't recruiting yet, so if I'm interested in it, how long might it realistically be before I could even be considered for enrollment, and what should I be doing in the meantime to manage my UC?
3The primary goal is clinical remission by Week 14 using the Full Mayo Score — is that a meaningful timeline and target for someone with my current severity of UC, and how does it compare to what we might expect from standard treatments?
4Since this is listed as Phase NA, which often means it's more of an observational or biomarker study rather than a treatment trial, does this involve trying a new medication, or would I continue on whatever therapy you'd already recommend for me?
5If this trial ends up being a good fit for me, would participating in it delay or replace starting a standard treatment for my UC, or could it run alongside whatever you'd normally prescribe?
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
1
Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14**