Investigating the Mediterranean Diet's Effects on Inflammatory Bowel Disease
Official title: Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
Run by University of California, San Diego · NCT05973500 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | August 1, 2028 |
| Study ends | August 1, 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT05973500 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with mild to moderate Crohn's Disease.
✕Probably not a fit
Patients with severe IBD, significant comorbidities, or those unable to adhere to dietary changes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While dietary interventions in IBD are gaining interest, this specific approach focusing on the Mediterranean diet is relatively novel and under-explored.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fecal Transplants from Dai vs Han Donors for Ulcerative Colitis
This study tests whether fecal microbiota transplantation from healthy Dai donors improves symptoms in adults with ulcerative colitis more than transplantation from healthy Han donors.
-
Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease
This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.
-
Breast milk mirikizumab levels in lactating people using mirikizumab for IBS/IBD
This study tests how much mirikizumab passes into breast milk for people who are breastfeeding while on mirikizumab for an approved condition.
-
Real-world use of guselkumab in Crohn’s disease and ulcerative colitis
This study tests how long guselkumab stays in the bodies of adults with moderate-to-severe Crohn’s disease or ulcerative colitis treated in real-world clinical settings.
-
Gut microbiome and metabolites in people with IBD and depression
This project will test whether gut microbes and metabolites differ in adults with IBD who have depression compared with those without depression and with healthy adults.
-
Real-world use of guselkumab for adults with moderate-to-severe ulcerative colitis and Crohn's disease in the UK
This project will see how well guselkumab works for adults with moderate-to-severe ulcerative colitis or Crohn's disease who are starting the treatment in routine UK care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.