Trials / Not Yet Recruiting
Not Yet RecruitingNCT07111572
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
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Qilu Hospital of Shandong University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | fecal calprotectin | patients will accpet test of FC combine FIT |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2026-08-01
- Completion
- 2026-12-01
- First posted
- 2025-08-08
- Last updated
- 2025-08-08
Source: ClinicalTrials.gov record NCT07111572. Inclusion in this directory is not an endorsement.