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

Article English OPEN
Alokail, Majed S ; Sabico, Shaun ; Al-Saleh, Yousef ; Al-Daghri, Nasser M ; Alkharfy, Khalid M ; Vanhoutte, Paul M ; McTernan, Philip G (2013)

Background:\ud 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.\ud Methods:\ud 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.\ud Discussion:\ud 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.\ud \ud Trial registration: ClinicalTrials.gov Identifier: NCT01765517
  • References (50)
    50 references, page 1 of 5

    1. Backhed F, Ley RE, Sonnenburg JL, Peterson DA, Gordon JI: Host-bacterial mutualism in the human intestine. Science 2005, 307:1915-1920.

    2. Husebye E, Hellstrom PM, Sundler F, Chen J, Midtvedt T: Influence of microbial species on small intestinal myoelectric activity and transit in germ-free rats. Am J Physiol Gastrointest Liver Physiol 2001, 280:G368-G380.

    3. O'Hara AM, Shanahan F: The gut flora as a forgotten organ. EMBO Rep 2006, 7:688-693.

    4. Al-Attas OS, Al-Daghri NM, Al-Rubeaan K, da Silva NF, Sabico SL, Kumar S, McTernan PG, Harte AL: Changes in endotoxin levels in T2DM subjects on anti-diabetic therapies. Cardiovasc Diabetol 2009, 8:20.

    5. Baker AR, Harte AL, Howell N, Pritlove DC, Ranasinghe AM, da Silva NF, Youssef EM, Khunti K, Davies MJ, Bonser RS, Kumar S, Pagano D, McTernan PG: Epicardial adipose tissue as a source of nuclear factorkappaB and c-Jun N-terminal kinase mediated inflammation in patients with coronary artery disease. J Clin Endocrinol Metab 2009, 94:261-267.

    6. Brun P, Castagliuolo I, Di Leo V, Buda A, Pinzani M, Palù G, Martines D: Increased intestinal permeability in obese mice: new evidence in the pathogenesis of nonalcoholic steatohepatitis. Am J Physiol Gastrointest Liver Physiol 2007, 292:G518-G525.

    7. Creely SJ, McTernan PG, Kusminski CM, Fisher M, Da Silva NF, Khanolkar M, Evans M, Harte AL, Kumar S: Lipopolysaccharide activates an innate immune system response in human adipose tissue in obesity and type 2 diabetes. Am J Physiol Endocrinol Metab 2007, 292:E740-E747.

    8. Miller M, McTernan P, Harte A, Silva N, Strazzullo P, Alberti K, Kumar S, Cappuccio F: Ethnic and sex differences in circulating endotoxin levels: a novel marker of atherosclerotic and cardiovascular risk in a British multi-ethnic population. Atherosclerosis 2009, 203:494-502.

    9. Harte AL, da Silva NF, Creely SJ, McGee KC, Billyard T, Youssef-Elabd EM, Tripathi G, Ashour E, Abdalla MS, Sharada HM, Amin AI, Burt AD, Kumar S, Day CP, McTernan PG: Elevated endotoxin levels in non-alcoholic fatty liver disease. J Inflamm (Lond) 2010, 30:7-15.

    10. Soares JB, Pimentel-Nunes P, Roncon-Albuquerque R, Leite-Moreira A: The role of lipopolysaccharide/toll-like receptor 4 signaling in chronic liver diseases. Hepatol Int 2010, 4:659-672.

  • Related Research Results (1)
  • Metrics
    No metrics available
Share - Bookmark