Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammatory Bowel Disease
- Sponsor
- University of California, San Diego
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- short Crohn's Disease Activity Index (sCDAI)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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 disease severity. The investigators will collect blood and stool samples from patients with inflammatory bowel disease (IBD) before and after diet changes. The stool samples will be analyzed using metabolomics and microbiome analysis to determine changes after the new diet has been implemented. The investigators will then compare changes in the patient's overall disease state by measuring markers of inflammation including C-reactive protein (CRP) and fecal calprotectin to determine how this diet affects the disease state.
Investigators
Monica Guma
Associate Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
short Crohn's Disease Activity Index (sCDAI)
Time Frame: 42 Days
Mild to moderate Crohn's Disease is defined by a short Crohn's Disease activity index (sCDAI) between 150-450, while those in remission from Crohn's Disease have an sCDAI score below 150. An sCDAI score exceeding 450 is used as a marker of severe Crohn's Disease.