Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07111572

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

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-08-01

Completion Date

2026-12-01

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

fecal calprotectin

patients will accpet test of FC combine FIT