NCT03201068

Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome

Completed NA Last updated 24 February 2023

What this trial tests

NA trial testing Probiotic supplement in Metabolic Syndrome in 42 participants. Completed in 4 December 2018.

Timeline

14 September 2017

Primary endpoint
16 November 2018

4 December 2018

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	42
Start date	14 September 2017
Primary completion	16 November 2018
Estimated completion	4 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Probiotic supplement — full drug profile →
• Placebo

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Microbiome — all drugs for Microbiome →
• Immune Function — all drugs for Immune Function →
• Inflammation — all drugs for Inflammation →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Metabolic Syndrome or Microbiome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized controlled trial demonstrates response to a probiotic intervention for metabolic syndrome that may correspond to diet.
   Wastyk HC, Perelman D, Topf M, Fragiadakis GK, et al · · 2023 · cited 35× · PMID 36803658 · DOI 10.1080/19490976.2023.2178794