Actively Recruiting
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
144
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 80 years
- Active inflammation of terminal ileum and/or colon with SES-CD > 5, or > 3 if isolated ileitis
- Patient reported outcome 2 (PRO2) score greater than 8
- Fecal calprotectin level above 250 µg/g
You will not qualify if you...
- Presence of abscess
- Bowel resection within 6 months before enrollment
- Having an ostomy
- Short-bowel syndrome
- Clinically significant stricture possibly requiring surgery
- Pregnant, lactating, or planning pregnancy during the study
- Unwilling or unable to follow the study diet
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Leuven
Leuven, Belgium
Actively Recruiting
Research Team
J
João PG Sabino, MD PhD
CONTACT
I
Isolde Aerden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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