Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502834
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-20
Brief Title:
Effect of 4 Weeks of Oral D Piger on Safety Pharmacokinetics and Ethanol Metabolism in Overweight Individuals 2023
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of 4 Weeks of Oral D Piger on Safety Pharmacokinetics and Ethanol Metabolism in Overweight Individuals 2023
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIGER
Brief Summary:
The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight
The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood and perform fecal analyses
The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood and perform fecal analyses
Detailed Description:
The investigators perform a randomized placebo controlled trial in 2x10 participants
The participants will be given placebo or d piger as an oral suspension once daily for 30 days
At baseline and after 30 days a fructose challenge test with fomepizole gastroduodenoscopy and MRI liver FibroScan will be performed Patient will attend the clinical trial unit weekly for safety visits
The participants will be overweight males or females age 18-70 with impaired glucose tolerance
The participants will be given placebo or d piger as an oral suspension once daily for 30 days
At baseline and after 30 days a fructose challenge test with fomepizole gastroduodenoscopy and MRI liver FibroScan will be performed Patient will attend the clinical trial unit weekly for safety visits
The participants will be overweight males or females age 18-70 with impaired glucose tolerance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None