COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Sponsored by Universitaire Ziekenhuizen KU Leuven
About this trial
Last updated a year ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the participation requirements?
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.