Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis
Not applicable · Testing Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL)… · Sites not listed yet · Qilu Hospital of Shandong University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: (a procedure) and Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). (a procedure) as a possible treatment. Condition(s) listed: Noninvasive Biomarkers and Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 240 participants are expected to take part.
- Start date: 2026-02-10 (planned).
- Main results expected around 2026-08-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Time to Treatment Failure (Composite) (week 52)
In the researchers’ words
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)
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Noninvasive Biomarkers; Ulcerative Colitis (UC) |
| Lead sponsor | Qilu Hospital of Shandong University |
| Collaborators | Qilu Hospital of Shandong University (Qingdao); Dezhou Hospital Qilu Hospital of Shandong University; Weihai Municipal Hospital; Jining First People's Hospital; Zaozhuang Municipal Hospital; Liaocheng People's Hospital; Weifang People's Hospital |
| Enrollment | 240 (estimated) |
| Start date | 2026-02-10 |
| Primary completion (est.) | 2026-08-30 |
| First posted | 2026-02-11 |
| Last updated | 2026-02-11 |
| Official title | Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial |
| ClinicalTrials.gov ID | NCT07402135 |
Interventions
- 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 (treatme… - 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).
Full eligibility criteria (from the record)
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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.