Effect of Mediterranean Diet in Inflammatory Bowel Disease

University of California San Diego

Status: Enrolling

Conditions: Inflammatory Bowel Disease

Treatments: Dietary Supplement: Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05973500

800805

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Mediterranean Diet

Experimental group

Description:

Mediterranean Diet for 42 Days

Treatment:

Dietary Supplement: Mediterranean Diet