Investigating the Mediterranean Diet's Effects on Inflammatory Bowel Disease
Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
This study is trying to see if switching to a Mediterranean diet can help people with inflammatory bowel disease feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05973500 on ClinicalTrials.gov |
What this trial studies
This study explores how dietary changes, specifically adopting a Mediterranean diet, can influence the severity of inflammatory bowel disease (IBD). Researchers will collect blood and stool samples from participants before and after implementing the diet to analyze changes in inflammation markers and gut microbiome composition. By comparing these samples, the study aims to determine the diet's impact on disease state and overall health in individuals with IBD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with mild to moderate Crohn's Disease.
Not a fit: Patients with severe IBD, significant comorbidities, or those unable to adhere to dietary changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide dietary recommendations that significantly improve the management of inflammatory bowel disease.
How similar studies have performed: While dietary interventions in IBD are gaining interest, this specific approach focusing on the Mediterranean diet is relatively novel and under-explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California
- University of California, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Monica Guma, M.D., PhD
- Email: mguma@health.ucsd.edu
- Phone: 8588226523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.