NCT07111273

DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis

Diagnostic Value of Quantitative Fecal Immunochemical Test (qFIT) and Calprotectin (FC) Dynamic Changes at 2 Weeks for Predicting 52-Week Relapse or Treatment Escalation in Biologic-Naive Ulcerative Colitis: A Multicenter, Prospective Cohort Study (DYNAMIC-UC)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This multicenter prospective cohort study aims to evaluate whether a \>50% decrease or normalization of both quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC) levels at 2 weeks after starting conventional therapy (mesalazine or corticosteroids) can predict clinical relapse or need for biologic/JAK inhibitor therapy escalation by 52 weeks in biologic-naive patients with active ulcerative colitis (UC). Secondary objectives include assessing predictive value at 4 weeks, building dynamic prediction models, conducting health economic evaluation (Number Needed to Test, NNT), and exploring baseline predictors of early biomarker response. Patients will be observed during standard care with stool samples collected at Weeks 0, 2, and 4. Biomarker results will be blinded to clinicians/patients until study completion.

Detailed description

This is a prospective, observational cohort study conducted across multiple centers in China. Biologic-naive UC patients (Mayo Endoscopic Subscore ≥2) initiating conventional therapy (mesalazine or corticosteroids) will be enrolled. Stool samples for quantitative FIT (qFIT) and fecal calprotectin (FC) will be collected at Baseline (Week 0) , Week 2 (±3 days) , and Week 4 (±3 days) . Patients are classified at Week 2: Group A (Rapid Responders): Both qFIT \& FC decrease \>50% from baseline OR normalize. Group B (Slow/Non-Responders): Either qFIT or FC decrease ≤50%. The primary endpoint is the composite event rate (clinical relapse OR treatment escalation to biologics/JAK inhibitors) by Week 52 (±2 weeks) . Clinical relapse is defined as an increase ≥2 points in partial Mayo score (excluding endoscopy) with a rectal bleeding subscore ≥1 requiring therapy adjustment. Treatment escalation occurs per standardized criteria (steroid-refractoriness or dependence). Secondary endpoints include time-to-event, corticosteroid-free remission, mucosal healing at Week 52, predictive model performance (AUC, sensitivity, specificity), NNT calculation, and baseline predictors.

Conditions

• Ulcerative Colitis (UC)
• Fecal Calprotetin
• FIT
• Biomarker

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FC and FIT TEST at WEEK0 2 4	FC and FIT TEST at WEEK0 2 4

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-31
• Completion: 2026-12-30
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: China