NCT07111572Recruiting
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07111572
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Aug 2025 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.