Ulcerative Colitis (UC), Fecal Calprotetin, FIT
Conditions
Keywords
UC, fecal calprotectin, FIT
Brief 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.
Interventions
DIAGNOSTIC_TESTfecal calprotectin
patients will accpet test of FC combine FIT
Sponsors
Qilu Hospital of Shandong University (Qingdao)
Dezhou Hospital Qilu Hospital of Shandong University
Weihai Municipal Hospital
Liaocheng People's Hospital
Jining First People's Hospital
Qilu Hospital of Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion achieving **clinical remission** (Full Mayo Score ≤2, no subscore >1) at **Week 14** | WEEK 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal healing (MES=0) at W52 | 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 |
Contacts
Primary ContactYan Zhang, M.D
Outcome results
None listed