NCT04938843

Effect of F. Prausnitzii on Glycemic Control

Effect of F. Prausnitzii on Glycemic Control - a Randomized, Double Blind, Placebo-controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: MetaboGen AB · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The microbiota is associated with a wide spectrum of diseases including diabetes and non-alcoholic fatty liver disease. In this study we will investigate if the bacteria F. prausnitzii, which is a part of the human gut microbiota, can improve metabolic parameters in subjects with impaired glucose control.

Detailed description

This is a randomized, double blind, placebo-controlled study. Subjects with impaired glucose control will after signing the informed consent and fulfilling the study criteria be randomized to study product or placebo. The randomization ratio between the study product (F. prausnitzii 1E8-5x1E8 CFU and D. piger) and placebo is 1:1. In total 176 subjects will be randomized in the study. The study will start with a Run-in period i.e. all the subjects will be given placebo capsules. The subjects fulfilling the inclusion and exclusion criteria will be randomized at Visit 2 to either study product or placebo in the ration 1:1. The treatment will last for 12 weeks, from Visit 2 to Visit 6. The study is ended with a 2-week period of follow up after the final dose. Blood samples are taken at Visits 1-4 and Visits 6-7. Feces samples are collected at Visit 2-7. One additional fecal sample will be sent by mail approximately one week after Visit 1. Glucose monitoring (CGM) will be initiated at Visit 1 and Visit 5 and followed for 10 days.

Conditions

• Pre Diabetes
• Impaired Glucose Tolerance
• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	F. prausnitzii and D. piger	Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
DIETARY_SUPPLEMENT	Placebo	Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks

Timeline

• Start date: 2021-08-16
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-06-24
• Last updated: 2021-09-02

Locations

1 site across 1 country: Sweden