Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Irritable Bowel Syndrome
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: The study will have two phases, Phase 1 will study healthy subjects, who will follow a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet for 2 weeks. Phase 2 will study subjects who have IBS-D. As above, they will first eat a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet.Masking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 has a substantial economic impact on society. The gut microbiome may play a significant role in the...

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 bidirectional brain-gut interaction. Recent studies suggest that the salutary impact of the Mediterranean diet may be due to its effects on the composition of the gut microbiome. In a recent cohort study in Italy, subjects who adhered most closely to a classical Mediterranean diet had more favorable bacterial enterotypes (e.g., Prevotella) in their stool, as well as higher levels of short-chain fatty acids - which are essential for colonic function. Studies have also showed that diet alters the predominant microbiome enterotypes and that microbiome composition can change quickly, within 24 hours, after a dietary intervention. Therefore, consumption of a Mediterranean diet may ameliorate the gut dysbiosis associated with IBS-D.

Tracking Information

NCT #
NCT03269032
Collaborators
Not Provided
Investigators
Principal Investigator: Richard B Weinberg, MD Wake Forest University Health Sciences