Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis (FORESEE-UC)

Shandong University

Status: Not yet enrolling

Conditions: Fecal Calprotetin; Ulcerative Colitis (UC); FIT

Treatments: Diagnostic Test: fecal calprotectin

Study type: Observational

Funder types: Other

Identifiers

NCT07111572

QILUGI-003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

100 participants in 1 patient group

UC patients accept therapy of biologics

Treatment:

Diagnostic Test: fecal calprotectin