Qilu Hospital of Shandong University
Jinan, Shandong, 251400, China
Location status: Recruiting
Recruiting
NCT Number: NCT07111572
Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
fecal calprotectin
Diagnostic Testpatients will accpet test of FC combine FIT
Primary outcomes
-
Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14**
Time frame: WEEK 14
Secondary outcomes
-
Mucosal healing (MES=0) at W52
Time frame: week 52
Clinical response rate (W14)
- Endoscopic improvement (MES ≤1) at W14
- Steroid-free clinical remission at W52
- Mucosal healing (MES=0) at W52
- ROC analysis of FC/FIT for predicting outcome
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Qilu Hospital of Shandong University
Other
Collaborators
- Dezhou Hospital Qilu Hospital of Shandong University
- Jining First People's Hospital
- Liaocheng People's Hospital
- Qilu Hospital of Shandong University (Qingdao)
- Weihai Municipal Hospital
Registry information
Official study 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
Acronym: FORESEE-UC
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 8, 2025
- Registry last updated
- Jul 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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