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

NCT07111572 · tracked via the Priya Life Science China tracker

Sponsor

Qilu Hospital of Shandong University

Phase

Observational

Started

2025-08-01

Last updated

2026-07-28

Condition(s) studied

Ulcerative Colitis (UC)Fecal CalprotetinFIT

Investigational drug(s) / intervention(s)

fecal calprotectin

fecal calprotectin: patients will accpet test of FC combine FIT

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14** — WEEK 14

Trial sites (1)

Facility	City	Region	Status
Qilu Hospital of Shandong University	Jinan	Shandong	Recruiting

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Other trials for the same condition

Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy（PRECAL） Enrolling by invitation

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07111572 on ClinicalTrials.gov ↗ ← All trials in China