Fecal Biomarker Response to Biologics in Ulcerative Colitis

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

This multicenter, prospective cohort follows adults with moderate-to-severe UC who are beginning a biologic therapy (vedolizumab or infliximab). It examines whether combined week 2 and week 4 changes in fecal calprotectin and FIT can forecast clinical remission at week 14 and mucosal healing at week 52. The primary outcome is clinical remission at week 14, with mucosal healing at week 52 as a key secondary endpoint. Participants will provide stool samples for FC and FIT measurements, with results correlated to clinical and endoscopic outcomes. The study is observational and aims to refine early-response testing to guide treatment decisions.

Why it matters

Who can join: the full rules

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

Where it's running

• Qilu Hospital of 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.