Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fecal calprotectin.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC), Fecal Calprotetin, FIT. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study
Overview
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.
Interventions
- Diagnostic test fecal calprotectin
patients will accpet test of FC combine FIT
Primary outcome measures
- Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14** [Time frame: WEEK 14]
Secondary outcome measures (1)
- Mucosal healing (MES=0) at W52 [Time frame: week 52]
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:\*\*
- Pregnancy/lactation
- Contraindications to biologics (e.g., active TB, severe infection)
- Experimental drug use within 4 weeks prior to baseline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT07111572 · QILUGI-003