Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-31 @ 5:15 AM
Study NCT ID:
NCT03269032
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mediterranean Diet and the Gut Microbiome
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Impact of the Mediterranean Diet on the Gut Microbiome and Symptoms of Diarrhea-Predominant Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 volunteers as well as in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) to see if the consumption of a Mediterranean-style diet has a positive effect on improving symptoms of IBS-D.
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: