Effect of Mediterranean Diet in Inflammatory Bowel Disease

NCT05973500 | Recruiting

• 1 other identifier: 800805
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• short Crohn's Disease Activity Index (sCDAI)

  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.

  42 Days

Study Arms (1)

Mediterranean Diet

EXPERIMENTAL

Mediterranean Diet for 42 Days

Dietary Supplement: Mediterranean Diet

Interventions

Mediterranean Diet DIETARY_SUPPLEMENT

Mediterranean Diet for 42 Days

Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92161, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Monica Guma, M.D., PhD

CONTACT

8588226523; mguma@health.ucsd.edu

Mehrnaz Aghili, M.D.

CONTACT

8582464721; maghili@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 3, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)