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NCT Number: NCT07402135

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

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)

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Key information

Conditions

Noninvasive Biomarkers Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:

Procedure

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).

Procedure

Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).

Primary outcomes

  1. Time to Treatment Failure (Composite)

    Time frame: week 52

    Time to Treatment Failure (Composite):

    Clinical relapse (pMS increase ≥2 + rectal bleeding ≥1). Need for corticosteroids due to UC relapse. UC-related hospitalization or surgery. Endoscopic worsening (MES >1).

Secondary outcomes

  1. Endoscopic remission rate (MES ≤1).

    Time frame: week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Zhang, M.D

CONTACT

[email protected]

+86 18560089821

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Dezhou Hospital Qilu Hospital of Shandong University
  • Jining First People's Hospital
  • Liaocheng People's Hospital
  • Qilu Hospital of Shandong University (Qingdao)
  • Weifang People's Hospital
  • Weihai Municipal Hospital
  • Zaozhuang Municipal Hospital

Registry information

Official study title

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

Acronym: FOCUS-UC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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