Effect of Mediterranean Diet in Inflammatory Bowel Disease

• Sponsor: University of California, San Diego (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05973500
• Collaborator: (none)
• Enrollment: 90
• Arm: 1
• Anticipated Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Dietary Supplement: Mediterranean Diet	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2028
• Anticipated Study Completion Date: Aug 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mediterranean Diet Mediterranean Diet for 42 Days	Dietary Supplement: Mediterranean Diet; Mediterranean Diet for 42 Days

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Monica Guma, Associate Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT05973500
• Other Study ID Numbers: 800805
• First Posted: Aug 3, 2023
• Last Update Posted: Aug 4, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

No Results Posted as of Aug 4, 2023