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

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether simple stool tests can help doctors see early on if a treatment is working for people with moderate-to-severe ulcerative colitis, a condition that causes inflammation in the colon. Specifically, the study looks at two stool markers called fecal calprotectin and fecal immunochemical test (FIT) at 2 and 4 weeks after starting certain biologic medicines (vedolizumab or infliximab). The goal is to find out if changes in these markers can predict how well patients feel by week 14 and if their colon heals by week 52.

Adults aged 18 to 75 with moderate-to-severe ulcerative colitis who are about to start one of these biologic treatments may be eligible. Participants should have a certain level of disease activity based on tests and should not be pregnant, breastfeeding, or have infections that make biologic treatment unsafe. During the study, participants will have stool samples collected early on after starting treatment and then be monitored to see how they respond. This study may help doctors better tailor treatments by identifying early who is likely to benefit from these medicines.

Gender

ALL

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