Recruiting

Diet & IBD

Sponsor:

UCLA

Code:

NCT05973500

Conditions

Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mediterranean Diet

Study Details

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.

Conditions

Inflammatory Bowel Disease

Study ID

NCT05973500

Start date

Sep 1, 2023

Status verified date

Apr, 2024

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mediterranean Diet

Mediterranean Diet for 42 Days

Interventions

Mediterranean Diet

Mediterranean Diet for 42 Days

Primary outcome measure

  • short Crohn's Disease Activity Index (sCDAI) [ Time Frame: 42 Days ]

Central Contacts and Locations

Central contacts

Monica Guma, M.D., PhD

8588226523mguma@health.ucsd.edu

Mehrnaz Aghili, M.D.

8582464721maghili@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92161

Contacts

Monica Guma, M.D, PHD

mguma@health.ucsd.edu

Principal Investigator:

Brigid Boland, M.D

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 2, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-04-02.