Status:
COMPLETED
Mediterranean Diet and the Gut Microbiome
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the impact of a Mediterranean-style diet on microbiome diversity compared to a typical American diet. The study will observe the microbiome composition comparisons in healthy ...
Detailed Description
Irritable bowel syndrome (IBS) is the most prevalent and well-studied functional gastrointestinal disorder. While IBS has no direct mortality, it does compromise quality of life, incurs morbidity, and...
Eligibility Criteria
Inclusion
- must be willing to eat pre-prepared foods for 4 weeks
- subjects must have no medical, religious, or cultural dietary restrictions that would preclude their eating a Mediterranean diet.
- Phase 2 subjects- must have diagnosis of IBS based on Rome III criteria and have diarrhea-predominant disease, defined as \>50% of bowel movements characterized as diarrhea
Exclusion
- history of gastrointestinal disease, including celiac disease, inflammatory bowel disease, or lactose intolerance
- diabetes mellitus
- congestive heart failure
- coronary artery disease
- chronic liver disease or end stage renal disease
- pregnancy or breastfeeding
- trainees under the direct supervision of the PI and patients receiving direct ongoing medical care from the PI or Co-I will not be enrolled as subjects in this study
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03269032
Start Date
October 10 2017
End Date
January 1 2021
Last Update
March 22 2023
Active Locations (1)
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1
Wake Forest Baptist Heath
Winston-Salem, North Carolina, United States, 27157