Early biomarker changes after standard UC therapy predict relapse in biologic-naive patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter, prospective cohort from China, researchers collect stool samples at baseline, week 2, and week 4 to measure qFIT and fecal calprotectin. Patients are grouped as rapid responders or slow/non-responders based on early biomarker changes, and the main outcome is relapse or escalation to biologics/JAK inhibitors by 52 weeks. Secondary analyses will assess time-to-event and mucosal healing, and a dynamic prediction model will be developed alongside an economic evaluation. Biomarker results are blinded to clinicians and patients during the study. The study population includes adults with active, biologic-naive ulcerative colitis initiating mesalazine or corticosteroids, with endoscopic disease activity and no prior biologic exposure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years.
* Established diagnosis of Ulcerative Colitis (UC) confirmed by clinical, endoscopic, and histopathological criteria.
* Endoscopic disease activity (Mayo Endoscopic Subscore ≥ 2) confirmed by colonoscopy during screening.
* Biologic-naive (no prior exposure to any biologic agent \[e.g., infliximab, adalimumab, vedolizumab, ustekinumab\] or JAK inhibitor).
* No use of systemic corticosteroids (oral or intravenous) within 4 weeks prior to Baseline (Week 0) visit.
* If using oral or rectal mesalazine/5-ASA preparations, dose must have been stable for ≥2 weeks prior to Baseline (Week 0).

Willing and able to provide written informed consent.

Exclusion Criteria:

* Diagnosis or high suspicion of Crohn's disease, ischemic colitis, infectious colitis, radiation colitis, intestinal tuberculosis, or other types of colitis.

Presence of other conditions clearly causing intestinal bleeding (e.g., acute hemorrhoidal bleeding, colorectal cancer, large colorectal polyps \>1cm, intestinal vascular malformations).

* Untreated systemic conditions that may cause intestinal bleeding (e.g., thrombocytopenia \[PLT \<50 x 10\^9/L\], severe coagulopathy).
* Regular use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban).
* Pregnancy or lactation.
* Any other condition deemed by the investigator to make the patient unsuitable for study participation.

Where it's running

• Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Yan Zhang, M.D.
• Email: qlzhangyan@sdu.edu.cn
• Phone: +86 18560089821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.