Effect of Mediterranean Diet in Inflammatory Bowel Disease

NCT ID: NCT05973500

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2028-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mediterranean Diet

Mediterranean Diet for 42 Days

Group Type EXPERIMENTAL

Mediterranean Diet

Intervention Type DIETARY_SUPPLEMENT

Mediterranean Diet for 42 Days

Interventions

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Mediterranean Diet

Mediterranean Diet for 42 Days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Monica Guma

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Guma, M.D., PhD

Role: CONTACT

8588226523

Mehrnaz Aghili, M.D.

Role: CONTACT

8582464721

Facility Contacts

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Monica Guma, M.D, PHD

Role: primary

Other Identifiers

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800805

Identifier Type: -

Identifier Source: org_study_id

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