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Effect of Mediterranean Diet in Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediterranean Diet
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of California, San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mediterranean Diet

Arm Description

Mediterranean Diet for 42 Days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
October 6, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05973500
Brief Title
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Official Title
Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
August 1, 2028 (Anticipated)
Study Completion Date
August 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Mediterranean Diet for 42 Days
Intervention Type
Dietary Supplement
Intervention Name(s)
Mediterranean Diet
Intervention Description
Mediterranean Diet for 42 Days
Primary Outcome Measure Information:
Title
short Crohn's Disease Activity Index (sCDAI)
Description
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.
Time Frame
42 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Guma, M.D., PhD
Phone
8588226523
Email
mguma@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mehrnaz Aghili, M.D.
Phone
8583991225
Email
maghili@health.ucsd.edu
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Guma, M.D, PHD
Email
mguma@health.ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Mediterranean Diet in Inflammatory Bowel Disease

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