RecruitingNCT07111572

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

Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study


Sponsor

Qilu Hospital of Shandong University

Enrollment

100 participants

Start Date

Aug 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying fecal calprotectin for people with fit, fecal calprotetin, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTfecal calprotectin

patients will accpet test of FC combine FIT


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT07111572


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