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NCT Number: NCT05973500

Effect of Mediterranean Diet in Inflammatory Bowel Disease

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.

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92161, United States

Location status: Recruiting

Location contact

Brigid Boland, M.D

PRINCIPAL_INVESTIGATOR

Monica Guma, M.D, PHD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean diet

Dietary Supplement

Mediterranean Diet for 42 Days

Primary outcomes

  1. short Crohn's Disease Activity Index (sCDAI)

    Time frame: 42 Days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehrnaz Aghili, M.D.

CONTACT

[email protected]

8582464721

Monica Guma, M.D., PhD

CONTACT

[email protected]

8588226523

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2023
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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