Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
Not yet recruiting
- Conditions
- Ulcerative Colitis (UC)Fecal CalprotetinFIT
- Registration Number
- NCT07111572
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14** WEEK 14
- Secondary Outcome Measures
Name Time Method Mucosal healing (MES=0) at W52 week 52 Clinical response rate (W14)
* Endoscopic improvement (MES ≤1) at W14
* Steroid-free clinical remission at W52
* Mucosal healing (MES=0) at W52
* ROC analysis of FC/FIT for predicting outcome