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

Max Nieuwdorp

Status and phase: Enrolling; Phase 1

Conditions: Steatosis of Liver; Obesity; Metabolic Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: D piger

Study type: Interventional

Funder types: Other

Identifiers

NCT06502834

2023.0787

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo vial (10ml of glycerol 10% and 10% maltrodextrin)

Treatment:

Dietary Supplement: Placebo

D piger

Experimental group

Description:

D. piger vial with 109 colony forming units (CFU) (=108 CFU D. piger per ml in 10ml of glycerol 10% and 10% maltrodextrin).

Treatment:

Dietary Supplement: D piger