Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT05702879
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Ozanimod — DRUG
    Start of standard therapy
  • TNF Inhibitor — DRUG
    Start of standard therapy
  • Steroids — DRUG
    Start of standard therapy
  • Vedolizumab — DRUG
    Start of standard therapy
  • Ustekinumab — DRUG
    Start of standard therapy

Study Details

The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.

Key Dates

Start date
Sep 6, 2023
Status verified
Nov 2023
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: Ulcerative colitis patients
    Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.
  • Arm: Controls
    For each patient, enrollment of a healthy control individual who shares the same living conditions (e.g., spouse or roommate) is attempted

Primary Outcome Measure

Development of a predictive score regarding success of anti-inflammatory therapy after start of a new treatment in ulcerative colitis [ Time Frame: 4 months ]

Central Contacts

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