RecruitingNot ApplicableNCT05973500

Effect of Mediterranean Diet in Inflammatory Bowel Disease

Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients


Sponsor

University of California, San Diego

Enrollment

90 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria10

  • 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

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Interventions

DIETARY_SUPPLEMENTMediterranean Diet

Mediterranean Diet for 42 Days


Locations(1)

University of California, San Diego

San Diego, California, United States

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NCT05973500


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