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

Last updated: July 1, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Treatment

FIT diet

Clinical Study ID

NCT04946448
S64746
  • Ages 18-80
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (18-80 years)

  • active inflammation of terminal ileum and/or colon with a Simple Endoscopic Scorefor Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients withisolated ileitis),

  • patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 dayaverage daily abdominal pain score x 5) > 8,

  • faecal calprotectin above 250 µg/g.

Exclusion

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 Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: FIT diet
Phase:
Study Start date:
September 14, 2021
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • University Hospital of Leuven

    Leuven,
    Belgium

    Active - Recruiting

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