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

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)

Inclusion Criteria:

1. Confirmed UC diagnosis ≥6 months.
2. Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1.
3. Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening.
4. Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks.
5. Written informed consent.

Exclusion Criteria:

1. Indeterminate colitis or Crohn's disease.
2. History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.
3. Systemic/local corticosteroid use within 8 weeks.
4. Active gastrointestinal infection or chronic diarrhea from non-UC causes.
5. Pregnancy, lactation, or concurrent interventional trial participation.