Tests stool markers to predict response to biologic treatment in ulcerative colitis
Checks stool markers in adults with ulcerative colitis starting biologic medicines.
Plain-language title generated from the registry record
Registry title: Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
Key facts
- Where
- Jinan, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07111572, who can take part
Where in China
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT07111572
- Record updated
- 28 July 2026
- Original description
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.Read full original descriptionShow less
Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study
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.
Inclusion: 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.