Authors

Shaun Sabico, Ayah Al-Mashharawi, Nasser M Al-Daghri, Sobhy Yakout, Abdullah M Alnaami, Majed S Alokail, Philip G McTernan

Year

2017

Journal

Journal of Translational Medicine

Abstract

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 × 109 cfu/g) containing the following bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium animalis subsp. lactis W52, Lactobacillus acidophilus W37, Levilactobacillus brevis W63, Lacticaseibacillus casei W56, Ligilactobacillus salivarius W24, Lactococcus lactis subsp. lactis W19 and Lactococcus lactis subsp. 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.