Intestinimonas for Prevention of Type 2 Diabetes Mellitus

Status Completed

Clinical Trial Summary

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Clinical Trial Description

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine. In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes. The key objective of this randomized, placebo-controlled study is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects. Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of Intestinimonas will be compared with the low-dose tested in the initial double-blind Randomised Controlled Trial (RCT). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04495972
Study type	Interventional
Source	Caelus Pharmaceuticals BV
Contact
Status	Completed
Phase	N/A
Start date	January 15, 2021
Completion date	November 10, 2023

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