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Impact of Probiotics on Drug, Vitamin, and Hormone Metabolism

Metabolism Clinical Trial

Official title:
Impact of Probiotics on Drug, Vitamin, and Hormone Metabolism

Clinical Trial Summary

This is an open-label, fixed sequence study of the effect of probiotics supplementation on drug, vitamin, and hormone metabolism.

Clinical Trial Description

The investigators hypothesize that probiotic treatment (Visbiome) will alter the activities of major classes of drug metabolizing enzymes. Twelve healthy male subjects will participate in a pharmacokinetic study prior to and following supplementation with Visbiome probiotics for 28 days.

The investigators will determine the pharmacokinetics of oral and intravenous midazolam [metabolized by cytochrome P450 3A enzymes, uridine 5'-diphospho-glucuronosyltransferases (UGTs) and sulfotransferase (SULTs)] and acetaminophen (metabolized by UGTs and SULTs), and the circulating concentrations of endogenous compounds (i.e., testosterone and vitamin D metabolites) prior to and following supplementation with Visbiome probiotics for 28 days. In addition, the investigators will compare the fecal microbiota composition and plasma lipidomic and metabolomics profiles to assess the impact of Visbiome supplementation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04281407
Study type Interventional
Source University of Washington
Contact Yvonne Lin, PhD
Phone 206-616-8728
Email yvonlin@uw.edu
Status Recruiting
Phase N/A
Start date January 3, 2020
Completion date August 31, 2020
View Details
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