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

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

Recruiting
18-70 years
All
Phase 1

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Overview

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.

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.

Eligibility

Inclusion

Male or (postmenopausal) females

  • Increased waist circumference (>102 cm men, 88>cm women)
  • Insulin resistance (HOMA>2.5)
  • 18-70 years

Exclusion Criteria:

  • Use of systemic medication (except for paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study period.
  • A history of a cardiovascular event
  • A history of cholecystectomy
  • Overt untreated gastrointestinal disease or abnormal bowel habits
  • Liver enzymes>2.5 fold higher than the upper limit of normal range
  • Smoking
  • Alcohol abuse

Study details
    Obesity
    Metabolic Syndrome
    Steatosis of Liver

NCT06502834

Max Nieuwdorp

14 October 2025

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