The efficacy and safety of probiotics intervention in preventing diabetes

The efficacy and safety of probiotics intervention in preventing conversion of impaired glucose tolerance to diabetes: study protocol for a randomized, double-blinded, placebo controlled trial of the Probiotics Prevention Diabetes Programme (PPDP)

Qun Yan, Xu Li and Bo Feng^*

• *Corresponding author: Bo Feng fengbo@medmail.com.cn

Author Affiliations

Department of Endocrinology, Shanghai East Hospital, Tongji University School of Medicine, Jimo Road 150, Shanghai, China

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BMC Endocrine Disorders 2015, 15:74  doi:10.1186/s12902-015-0071-9

The electronic version of this article is the complete one and can be found online at:http://www.biomedcentral.com/1472-6823/15/74

Received:	26 October 2015
Accepted:	17 November 2015
Published:	1 December 2015

© 2015 Yan et al. 

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Abstract

Background

Alterations in intestinal microbiota correlate with risk of development of obesity and type 2 diabetes. Probiotics have been suggested to play an important role in the management of dysglycemia, although the evidence is limited. In this study, we aim to explore the efficacy and safety of probiotics intervention in preventing type 2 diabetes in Chinese patients with impaired glucose tolerance.

Methods/Design

A 24-month randomized intervention is conducted from January 2014 to December 2016. The target sample size for intervention is 200 middle-aged men and women aged 30–65 year-old with impaired glucose tolerance. Participants with persistent impaired glucose tolerance were assigned to group A (tablet A) and B (tablet B) in sequential order. The participants and investigators were blinded to the assignment. The primary outcome is development of diabetes. The secondary outcome measures include body composition, biochemical variables and the safety of the probiotics.

Discussion

The results from this trial will provide the evidence on the efficacy and safety of probiotics administration in preventing conversion of impaired glucose tolerance to diabetes in a Chinese context.

Trial registration

ChiCTRTRC13004024

Fuente: http://www.biomedcentral.com/1472-6823/15/74