Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation.

BMJ Open Diabetes Research & Care
Fanny PerraudeauOrville Kolterman

Abstract

A growing body of evidence suggests that specific, naturally occurring gut bacteria are under-represented in the intestinal tracts of subjects with type 2 diabetes (T2D) and that their functions, like gut barrier stability and butyrate production, are important to glucose and insulin homeostasis. The objective of this study was to test the hypothesis that enteral exposure to microbes with these proposed functions can safely improve clinical measures of glycemic control and thereby play a role in the overall dietary management of diabetes. We evaluated whether a probiotic comprised of these anaerobic bacteria would enhance dietary management by (1) manufacturing two novel probiotic formulations containing three (WBF-010) or five (WBF-011) distinct strains in a Current Good Manufacturing Practice (cGMP) facility, (2) establishing consistent live-cell concentrations, (3) confirming safety at target concentrations dispensed in both animal and human studies and (4) conducting a 12-week parallel, double-blind, placebo-controlled, proof-of-concept study in which subjects previously diagnosed with T2D (n=76) were randomly assigned to a two times a day regimen of placebo, WBF-010 or WBF-011. No safety or tolerability issues were observe...Continue Reading

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Citations

Oct 25, 2020·Journal of Applied Microbiology·Yu XiaoChunli Song
Feb 9, 2021·Trends in Microbiology·Marla CunninghamGlenn R Gibson
Mar 5, 2021·JMIR Formative Research·Hector Roux de BézieuxFanny Perraudeau
Apr 1, 2021·Best Practice & Research. Clinical Endocrinology & Metabolism·Thi Phuong Nam Bui, Willem M de Vos
May 9, 2021·Cell Death and Differentiation·Safae TerrisseLaurence Zitvogel
Aug 29, 2021·Nature Reviews. Gastroenterology & Hepatology·Daniel A SchupackPurna C Kashyap

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Methods Mentioned

BETA
amplicon sequencing
amputation

Clinical Trials Mentioned

NCT03893422

Software Mentioned

R
CONSORT
Statistical Analysis Plan

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