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Not yet recruiting NCT07402135

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

No phase Interventional Noninvasive Biomarkers Ulcerative Colitis (UC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:, Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1)..
Who it may be relevant to
Registry conditions: Noninvasive Biomarkers, Ulcerative Colitis (UC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

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).

Primary outcome measures

  • Time to Treatment Failure (Composite) [Time frame: week 52]
Secondary outcome measures (1)
  • Endoscopic remission rate (MES ≤1). [Time frame: week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07402135 · QILUGI-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗