Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
Recruiting
Observational Study
Ulcerative Colitis (UC)
Fecal Calprotetin
FIT
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- Qilu Hospital of Shandong University · Other
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About This Trial
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: clinica…
Trial Locations
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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:\…
Contacts