Effect of Mediterranean Diet in Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mediterranean Diet.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
Overview
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.
Interventions
- Dietary supplement Mediterranean Diet
Mediterranean Diet for 42 Days
Primary outcome measures
- short Crohn's Disease Activity Index (sCDAI) [Time frame: 42 Days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Diego — San Diego
Identifiers
NCT: NCT05973500 · 800805