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Background  The present randomized clinical trial characterized the beneficial effects of a multi-strain probiotics supplementation on improving circulating endotoxin levels (primary endpoint) and other cardiometabolic biomarkers (secondary endpoint) in patients with T2DM.    Methods  A total of 78 adult Saudi T2DM patients (naïve and without co-morbidities) participated in this clinical trial and were randomized to receive twice daily placebo or probiotics [(2.5 × 10 9  cfu/g) containing the following bacterial strains:  Bifidobacterium bifidum  W23,  Bifidobacterium lactis  W52,  Lactobacillus acidophilus  W37,  Lactobacillus brevis  W63,  Lactobacillus casei  W56,  Lactobacillus salivarius  W24,  Lactococcus lactis  W19 and  Lactococcus lactis  W58 (Ecologic ® Barrier)] in a double-blind manner for 12 weeks. Anthropometrics and cardiometabolic profiles were obtained at baseline and after 12/13 weeks of treatment.    Results  After 12/13 weeks of intervention and using intention-to-treat analysis, no difference was noted in endotoxin levels between groups [Placebo − 9.5% vs. Probiotics − 52.2%; (CI − 0.05 to 0.36; p = 0.15)]. Compared with the placebo group however, participants in the probiotics groups had a significant but modest improvement in WHR [Placebo 0.0% vs. Probiotics 1.11%; (CI − 0.12 to − 0.01; p = 0.02)] as well as a clinically significant improvement in HOMA-IR [Placebo − 12.2% vs. Probiotics − 60.4%; (CI − 0.34 to − 0.01; p = 0.04)].    Conclusion  Using a multi-strain probiotic supplement daily for 12/13 weeks significantly improved HOMA-IR and modestly reduced abdominal adiposity among medication naïve T2DM patients.    Trial Registration : ClinicalTrials.gov Identifier:  NCT01765517 , Registered January 10, 2013    Electronic supplementary material  The online version of this article (10.1186/s12967-017-1354-x) contains supplementary material, which is available to authorized users.

journal of translational medicine

Effects of a multi-strain probiotic supplement for 12 weeks in circulating endotoxin levels and cardiometabolic profiles of medication naïve T2DM patients: a randomized clinical trial