RECRUITINGINTERVENTIONAL
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
FIT diet
Dietary intervention as add-on therapy to biologicals
Locations (1)
University Hospital of Leuven
Leuven, Belgium