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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combining the FIT diet with biological therapy in adults with Crohn's disease. This randomized open-label trial compares the FIT diet to a standard diet in patients receiving biological treatment, aiming to assess steroid-free clinical and biochemical remission at 6 months as the primary outcome. Participants are assigned to one of two groups: those receiving biological treatment alongside the FIT diet, and those receiving biological treatment with a standard diet. The study monitors clinical response, remission, endoscopic improvements, biomarkers like CRP and fecal calprotectin, nutritional status, fatigue, and health-related quality of life over 6 months and up to 1 year. During the study, participants undergo evaluations of clinical symptoms, endoscopic assessments, and laboratory tests. Researchers track adherence to the diet and biological therapy, measuring outcomes such as steroid-free remission, inflammatory markers, and quality of life. The study runs from enrollment through 1 year with regular assessments to monitor progress and safety.
CONDITIONS
Brief 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 for isolated ileitis)
- Patient reported outcome 2 (PRO2) score greater than 8
- Faecal calprotectin above 250 µg/g
You will not qualify if you...
- Presence of abscess
- Bowel resection within 6 months before enrollment
- Ostomy
- Short-bowel syndrome
- Clinically significant stricture that may require surgery
- Pregnant women
- Lactating women or desire to become pregnant during the study
- Unwilling or unable to follow the study diet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive biological treatment combined with either the FIT diet or the standard diet as part of the study intervention.
Visits as per treatment schedule over 6 months
Duration - Up to 1 year
Participants are monitored for clinical response, remission, and other health outcomes up to 1 year after starting treatment.
Periodic visits up to 1 year
Trial Site Locations
Total: 1 location
1
University Hospital of Leuven
Leuven, Belgium
Actively Recruiting
Research Team
J
João PG Sabino, MD PhD
I
Isolde Aerden
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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