Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05973500

Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients

Led by University of California, San Diego · Updated on 2024-04-02

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how diet affects inflammatory bowel disease (IBD), focusing on how dietary changes may influence the severity of IBD symptoms. This study aims to better understand the impact of diet on inflammation and disease activity in patients with IBD, including those with Crohn's Disease. The University of California, San Diego is leading this research to explore these effects using biological samples and disease markers. Participants will follow a Mediterranean Diet for 42 days as the main intervention. During this period, the diet's influence on the patients’ health will be monitored through various tests, including blood and stool sample collections. These samples will undergo metabolomics and microbiome analysis to observe changes linked to the diet. The study will assess disease activity using markers such as C-reactive protein and fecal calprotectin. Throughout the study, patients will provide blood and stool samples before and after the diet intervention. Researchers will measure disease activity using the short Crohn's Disease Activity Index after 42 days on the diet. The study involves regular monitoring of inflammation markers to evaluate how the Mediterranean Diet affects the disease state. Participants will be followed for the duration of the 42-day diet period to observe these changes.

CONDITIONS

Brief Title

Effect of Mediterranean Diet in Inflammatory Bowel Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Meet classification criteria for inflammatory bowel disease
  • Have mild to moderate Crohn's Disease with a Crohn's disease activity index between 150-450
  • Fecal calprotectin greater than 250 within 1 month of enrollment
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • History of or current drug abuse
  • Pregnancy
  • Started or changed dose of standard-of-care treatment within 12 weeks of screening
  • Known allergy to any component of the proposed diet
  • Significant other medical or psychiatric conditions or medications that may affect results
  • Not on a stable dose of medications such as steroids between sample collections
  • Currently taking antibiotics
  • C difficile infection within 4 weeks of enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 42 days

Participants follow a Mediterranean Diet to manage their inflammatory bowel disease.

Visits as per dietary adherence monitoring

Trial Site Locations

Total: 1 location

1

University of California, San Diego

San Diego, California, United States, 92161

Actively Recruiting

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Research Team

M

Monica Guma, M.D., PhD

M

Mehrnaz Aghili, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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