RecruitingNot ApplicableNCT04946448
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
144 participants
Start Date
Sep 14, 2021
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria8
- 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.
Interventions
OTHERFIT diet
Dietary intervention as add-on therapy to biologicals
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04946448
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