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

NCT07402135 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-02-11

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Qilu Hospital of Shandong University (Qingdao)

    collaborator OTHER

  • Dezhou Hospital Qilu Hospital of Shandong University

    collaborator OTHER

  • Weihai Municipal Hospital

    collaborator OTHER

  • Jining First People's Hospital

    collaborator OTHER

  • Zaozhuang Municipal Hospital

    collaborator OTHER

  • Liaocheng People's Hospital

    collaborator OTHER

  • Weifang People's Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2026-08-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07402135 on ClinicalTrials.gov