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

Recruiting now

Conditions studied: Ulcerative Colitis (UC), Fecal Calprotetin, FIT

In brief

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.

Key facts

Study ID

NCT07111572

Run by

Qilu Hospital of Shandong University

People needed

100

Starts

2025-08-01

Expected to finish

2026-12-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnancy/lactation
• Contraindications to biologics (e.g., active TB, severe infection)
• Experimental drug use within 4 weeks prior to baseline

Where it is running

• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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