NCT06502834

Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Max Nieuwdorp · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obesity
• Metabolic Syndrome
• Steatosis of Liver

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	D piger	Probiotic d piger
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: Netherlands