RECRUITING

Effect of Mediterranean Diet in Inflammatory Bowel Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients

Quick Facts

Study Start:2023-09-01
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05973500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years old or older
  2. * 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.
  1. * Unable to provide informed consent
  2. * History of or current drug abuse
  3. * Pregnancy
  4. * Start or change in dose of standard-of-care treatment within 12 weeks of the screening
  5. * Known allergy to any component of the proposed diet
  6. * Subjects with significant other medical or psychiatric comorbidities and /or medication use which in
  7. * physician's clinical judgment might difficult the interpretation of the results
  8. * Patients that are not on a stable dose of medications, for instance, steroids, in between samples collection
  9. * Patients on antibiotics
  10. * Patients with C difficile infection within 4 weeks of enrollment

Contacts and Locations

Study Contact

Monica Guma, M.D., PhD
CONTACT
8588226523
mguma@health.ucsd.edu
Mehrnaz Aghili, M.D.
CONTACT
8582464721
maghili@health.ucsd.edu

Study Locations (Sites)

University of California, San Diego
San Diego, California, 92161
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2028-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Inflammatory Bowel Disease