Open Access Highly Accessed Study protocol

Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial

Majed S Alokail127*, Shaun Sabico16, Yousef Al-Saleh3, Nasser M Al-Daghri12, Khalid M Alkharfy14, Paul M Vanhoutte15 and Philip G McTernan6

Author Affiliations

1 Biomarkers Research Program, King Saud University, Riyadh, 11451, Saudi Arabia

2 Center of Excellence in Biotechnology Research, King Saud University, Riyadh, 11451, Saudi Arabia

3 College of Medicine, King Saud University for Health Sciences, Riyadh, 11451, Saudi Arabia

4 College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia

5 Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, 21 Sassoon Road, Hong Kong, China

6 Division of Metabolic and Vascular Health, Warwick Medical School, Clinical Sciences Research Laboratories, University Hospital Coventry and Warwickshire, Walsgrave, Coventry, CV2 2DX, United Kingdom

7 Biochemistry Department, College of Science, King Saud University, PO Box, 2455, Riyadh, 11451, Kingdom of Saudi Arabia

For all author emails, please log on.

Trials 2013, 14:195  doi:10.1186/1745-6215-14-195

Published: 4 July 2013

Abstract

Background

Low grade chronic inflammation is observed in patients with type 2 diabetes mellitus (T2DM). Endotoxin derived from gut bacteria may act as a potent inflammatory stimulant. Probiotics, which are believed to contain health promoting live microorganisms, may influence circulating endotoxin levels. Ingestion of live probiotic cultures may alter gut microbiota in a beneficial manner to reduce inflammation; no information is available whether or not they do so in patients with T2DM. Therefore, the aim of this study is to characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low-grade inflammation in patients with T2DM.

Methods

One hundred and twenty consenting adult Saudi T2DM patients (naïve or newly diagnosed and without co-morbidities) will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics (Ecologic®Barrier) for 26 weeks in a double-blind manner. Inflammatory and metabolic markers will be measured and fecal samples analyzed. Measurements/samples will be obtained at baseline and after 4, 8, 12/13 and 26 weeks of treatment.

Discussion

It is expected that the probiotic product will induce beneficial changes in gut microbiota, reduce the systemic inflammatory state through altering systemic endotoxin levels and, as such, reduce the systemic inflammatory response observed in T2DM subjects.

Trial registration

ClinicalTrials.gov Identifier: NCT01765517

Keywords:
Type 2 diabetes mellitus; Endotoxin; Microbiota; Probiotics