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Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis
Sponsor: Qilu Hospital of Shandong University
Summary
Design: Multicenter, Open-Label, Randomized, Parallel Controlled Allocation: 1:1 Randomization Masking: Open-label (outcome assessors blinded for endoscopy) Primary Purpose: Treatment Strategy Evaluation Phase: Phase IV (Post-Marketing Surveillance)
Official title: Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-02-10
Completion Date
2026-12-31
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:
Preemptive therapy escalation based on preset thresholds (FC \>250 μg/g or FIT \>100 ng/mL) using the FOCUS-UC Ladder: Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure).
Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).