Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
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: clinical remission rate at Week 14.
Eligibility criteria
Qualifiers
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
Disqualifiers
Pregnancy/lactation
Contraindications to biologics (e.g., active TB, severe infection)
Experimental drug use within 4 weeks prior to baseline
Trial design
Treatments tested in this trial
- fecal calprotectin
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Qilu Hospital of Shandong University
Lead sponsor
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Dezhou Hospital Qilu Hospital of Shandong University
Collaborator
Weihai Municipal Hospital
Collaborator
Liaocheng People's Hospital
Collaborator
Jining First People's Hospital
Collaborator
Source ClinicalTrials.gov