Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 5:13 PM
Study NCT ID:
NCT06502834
Status:
RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Sponsor:
Max Nieuwdorp
Organization:
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:
False
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:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: