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NCT07111572
Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
Conditions: Ulcerative Colitis (UC), Fecal Calprotetin, FIT
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: Qilu Hospital of Shandong University
Location: Qilu Hospital of Shandong University Jinan Shandong
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 Criteria
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
Source: ClinicalTrials.gov (NCT07111572). StuddyBuddy aggregates publicly available trial information.
