Effect of Mediterranean Diet in Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Disease
• Interventions: Dietary Supplement: Mediterranean Diet

• Registration Number: NCT05973500
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-03
• Study Start: 2023-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mediterranean Diet	Mediterranean Diet	Mediterranean Diet for 42 Days

Primary Outcome Measures

Name	Time	Method
short Crohn's Disease Activity Index (sCDAI)	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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States