Clinical Trials Directory

Trials / Completed

CompletedNCT03201068

Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome

Impact of a Probiotic Supplement on the Microbiome, Immune System, and Metabolic Syndrome

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This study will define the impact of a probiotic supplement on microbiome, immune system, and metabolic syndrome. This study will determine the degree to which a probiotic supplement can 1) improve metabolic markers and metrics of metabolic syndrome, 2) alter microbiota composition and function, 3) impact microbiota metabolites, short-chain fatty acids-potential normalizers of metabolic and immune dysfunction, and 4) regulate immune status and function including reducing chronic, systemic inflammation as assessed by high dimensional immune profiling.

Detailed description

The centrality of the gut microbiota to human health has emerged in just the last decade, with the last three years implicating our modern, deteriorated gut microbiota in numerous chronic diseases. It is likely dietary changes in the last half-century consistent with adoption of the Western diet have had an adverse impact on the gut microbiota. A critically important next step in this field of research is to identify how different probiotic supplements can potentially restore the microbiota in alignment with the optimization of human health, particularly in regard to the reversal or prevention of chronic diseases including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed to elicit and contrast the amount of increase in microbiota diversity and related metabolic output achievable following consumption of a probiotic supplement commonly available to the general population. The results could contribute to dietary recommendations for reversing the chronic disease epidemics of westernization.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTProbiotic supplementProbiotic supplement capsule
DIETARY_SUPPLEMENTPlaceboPlacebo capsule

Timeline

Start date
2017-09-14
Primary completion
2018-11-16
Completion
2018-12-04
First posted
2017-06-28
Last updated
2023-02-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03201068. Inclusion in this directory is not an endorsement.