NCT07402135

Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis

Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Noninvasive Biomarkers
• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	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).

Timeline

• Start date: 2026-02-10
• Primary completion: 2026-08-30
• Completion: 2026-12-31
• First posted: 2026-02-11
• Last updated: 2026-02-11