Mediterranean Diet and the Gut Microbiome
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Aug 30, 2017
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
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 has a substantial economic impact on society. The gut microbiome may play a significant role in the pathogenesis of IBS. Even though the exact mechanisms underlying this relationship have not been presented, it is suggested that certain microorganisms may increase gut permeability, activate the mucosal immune response, increase visceral sensitivity and alter intestinal motility via a bidirecti...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Richard B Weinberg, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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