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Effects of probiotics in patients with diabetes mellitus type 2 : study protocol for a randomized, double-blind, placebo-controlled trial
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Alokail, Majed S., Sabico, Shaun, Al-Saleh, Yousef, Al-Daghri, Nasser M., Alkharfy, Khalid M., Vanhoutte, Paul M. and McTernan, P. G. (Philip G.) (2013) Effects of probiotics in patients with diabetes mellitus type 2 : study protocol for a randomized, double-blind, placebo-controlled trial. Trials, Volume 14 (Number 1). Article number 195. doi:10.1186/1745-6215-14-195
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Official URL: http://dx.doi.org/10.1186/1745-6215-14-195
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
| Item Type: | Journal Article | ||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Biomedical Sciences > Translational & Experimental Medicine > Metabolic and Vascular Health (- until July 2016) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Diabetes -- Research, Endocrine glands -- Diseases , Gastrointestinal system, Gastrointestinal system -- Microbiology, Probiotics , Clinical trials | ||||
| Journal or Publication Title: | Trials | ||||
| Publisher: | Biomed Central | ||||
| ISSN: | 1745-6215 | ||||
| Official Date: | 4 July 2013 | ||||
| Dates: |
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| Volume: | Volume 14 | ||||
| Number: | Number 1 | ||||
| Page Range: | Article number 195 | ||||
| DOI: | 10.1186/1745-6215-14-195 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Open Access | ||||
| Funder: | National Plan for Science and Technology (Saudi Arabia) | ||||
| Grant number: | 11-MED2114-02 |
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