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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic supplement | Probiotic supplement capsule |
| DIETARY_SUPPLEMENT | Placebo | Placebo 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.