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Search / Trial NCT03269032

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

Mediterranean Diet Gut Microbiome Gastrointestinal

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.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 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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