Status:
RECRUITING
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Lead Sponsor:
University of California, San Diego
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The effects of diet on inflammatory bowel disease is an under-studied area of research. The investigators are interested in further investigating the role that diet contributes to inflammatory bowel d...
Eligibility Criteria
Inclusion
- 18 years old or older
- Meet classification criteria for inflammatory bowel disease including those with mild to moderate Crohn's Disease as defined by a Crohn's disease activity index between 150-450, with fecal calprotectin\>250, within 1 month of enrollment.
Exclusion
- Unable to provide informed consent
- History of or current drug abuse
- Pregnancy
- Start or change in dose of standard-of-care treatment within 12 weeks of the screening
- Known allergy to any component of the proposed diet
- Subjects with significant other medical or psychiatric comorbidities and /or medication use which in
- physician's clinical judgment might difficult the interpretation of the results
- Patients that are not on a stable dose of medications, for instance, steroids, in between samples collection
- Patients on antibiotics
- Patients with C difficile infection within 4 weeks of enrollment
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05973500
Start Date
September 1 2023
End Date
August 1 2028
Last Update
April 2 2024
Active Locations (1)
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1
University of California, San Diego
San Diego, California, United States, 92161