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

N/ANot Yet RecruitingNCT07111572

Qilu Hospital of Shandong University100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Ulcerative Colitis (UC)Fecal Calprotetin FIT

Interventions

fecal calprotectinDIAGNOSTIC_TEST

patients will accpet test of FC combine FIT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: WEEK 14

Secondary Outcomes

Mucosal healing (MES=0) at W52

Clinical response rate (W14) * Endoscopic improvement (MES ≤1) at W14 * Steroid-free clinical remission at W52 * Mucosal healing (MES=0) at W52 * ROC analysis of FC/FIT for predicting outcome

Time frame: week 52

Central Contacts

Yan Zhang, M.D

CONTACT

+86 18560089821 qlzhangyan@sdu.edu.cn

Data from ClinicalTrials.gov

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