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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05973500
Other study ID # 800805
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date August 1, 2028

Study information

Verified date April 2024
Source University of California, San Diego
Contact Monica Guma, M.D., PhD
Phone 8588226523
Email mguma@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date August 1, 2028
Est. primary completion date August 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Mediterranean Diet
Mediterranean Diet for 42 Days

Locations

Country Name City State
United States University of California, San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary short Crohn's Disease Activity Index (sCDAI) Mild to moderate Crohn's Disease is defined by a short Crohn's Disease activity index (sCDAI) between 150-450, while those in remission from Crohn's Disease have an sCDAI score below 150. An sCDAI score exceeding 450 is used as a marker of severe Crohn's Disease. 42 Days
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