NCT05973500 Effect of Mediterranean Diet in Inflammatory Bowel Disease
| NCT ID | NCT05973500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Inflammatory Bowel Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-09-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05973500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05973500 currently recruiting?
Yes, NCT05973500 is actively recruiting participants. Contact the research team at mguma@health.ucsd.edu for enrollment information.
Where is the NCT05973500 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT05973500 clinical trial?
NCT05973500 is sponsored by University of California, San Diego. The trial plans to enroll 90 participants.