NCT04281407

Impact of Probiotics on Drug, Vitamin, and Hormone Metabolism

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Metabolism

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Visbiome	2 capsules of Visbiome, a probiotics supplement, twice a day (morning and evening) for 28 days

Timeline

• Start date: 2020-01-03
• Primary completion: 2020-06-30
• Completion: 2020-08-31
• First posted: 2020-02-24
• Last updated: 2020-02-24

Locations

1 site across 1 country: United States