Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis (FOCUS-UC)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis (UC); Noninvasive Biomarkers
• Intervention / Treatment: Procedure: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:; Procedure: Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Zhang, M.D; Phone Number: +86 18560089821; Email: qlzhangyan@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tight Control (TC) Strategy; Fecal calprotectin (FC) and FIT measured at Weeks 0, 12, 24, 36. Action: 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: 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).
Placebo Comparator: Conventional Management (CM) Strategy	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Failure (Composite)	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).	week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Endoscopic remission rate (MES ≤1).	week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: QILUGI-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No