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: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Yan Zhang, M.D
qlzhangyan@sdu.edu.cn
+86 18560089821
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 100
Treatments
UC patients accept therapy of biologics
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University
Collaborators: Dezhou Hospital Qilu Hospital of Shandong University, Liaocheng People's Hospital, Jining First People's Hospital, Weihai Municipal Hospital, Qilu Hospital of Shandong University (Qingdao)