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COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study

COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study

Recruiting
18-80 years
All
Phase N/A

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Overview

This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic therapy.

Eligibility

Inclusion Criteria:

  • Adult patients (18-80 years)
  • active inflammation of terminal ileum and/or colon with a Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients with isolated ileitis),
  • patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 day average daily abdominal pain score x 5) > 8,
  • faecal calprotectin above 250 µg/g.

Exclusion Criteria:

  • Abcess,
  • Bowel resection within 6 months before enrolment,
  • Ostomy,
  • Short-bowel syndrome,
  • Clinically significant stricture that could require surgery,
  • Pregnant,
  • Lactating woman or desire to become pregnant during the study,
  • Unwilling or unable to follow the study diet.

Study details
    Crohn Disease
    Inflammatory Bowel Diseases
    Diet
    Healthy

NCT04946448

Universitaire Ziekenhuizen KU Leuven

21 October 2025

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