COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Recruiting
N/A
Interventional Study
Crohn Disease
Inflammatory Bowel Diseases
Diet, Healthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 144 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 f…
Contacts