Effect of Mediterranean Diet in Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

Official title:

Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973500
• Other study ID #: 800805
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 1, 2028

Study information

• Verified date: April 2024
• Source: University of California, San Diego
• Contact: Monica Guma, M.D., PhD
• Phone: 8588226523
• Email: mguma[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2028
• Est. primary completion date: August 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Dietary Supplement:
• Mediterranean Diet
Mediterranean Diet for 42 Days

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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