NCT07402135Not yet recruiting
Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis
Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- Feb 2026
- Primary completion date
- Aug 2026
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07402135
What you commit to
- Study type: Interventional
- Planned participants: 240
- From Feb 2026 to the primary completion date, Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.
- Systemic/local corticosteroid use within 8 weeks.
- Pregnancy, lactation, or concurrent interventional trial participation.
Other illness
- Indeterminate colitis or Crohn's disease.
- Active gastrointestinal infection or chronic diarrhea from non-UC causes.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.