Effect of Mediterranean Diet in Inflammatory Bowel Disease
Not applicable · Testing Mediterranean Diet · 1 site · University of California, San Diego
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Mediterranean Diet (a dietary supplement) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 90 participants are expected to take part.
- Start date: 2023-09-01.
- Main results expected around 2028-08-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- short Crohn's Disease Activity Index (sCDAI) (42 Days)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | University of California, San Diego |
| Enrollment | 90 (estimated) |
| Start date | 2023-09-01 |
| Primary completion (est.) | 2028-08-01 |
| First posted | 2023-08-03 |
| Last updated | 2024-04-02 |
| Official title | Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients |
| ClinicalTrials.gov ID | NCT05973500 |
Interventions
- Mediterranean Diet (Dietary Supplement)
Mediterranean Diet for 42 Days
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, San Diego | San Diego, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.