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

Abstract

BackgroundThe 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.MethodsA 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 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.ResultsAfter 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)].ConclusionUsing 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, 2013Electronic supplementary materialThe online version of this article (10.1186/s12967-017-1354-x) contains supplementary material, which is available to authorized users.

Dietary Momordica Cochinchinensis aril ameliorates metabolic dysfunction, nonalcoholic fatty liver, and gut microbiota in diet-induced obese mice

“…Interestingly, our data showed that the relative abundance of the family Bifidobacteriaceae and Bifidobacterium bifidum was higher in the MCA group than the HFD group. Previous studies showed that the probiotics containing Bifidobacterium bifidum plays important role to prevent and treat patients with obesity and insulin resistance [45,46]. Our data showed that MCA treatment increase Bifidobacterium bifidum in HFD-fed mice ( Fig.…”

The Potential of Probiotics in the Prevention and Treatment of Atherosclerosis

“…However, the association between probiotic treatment and diabetes is less clear with a small number of studies showing no such association . For example, in a recent clinical trial, type 2 diabetic patients receiving a consortium of eight different probiotic strains exhibited significantly higher median glucose levels, in addition to higher circulating TC and LDL‐C …”

A Mini-Review of Human Studies on Cholesterol-Lowering Properties of Probiotics

“…Only a non-significant increase in HDL-C level was observed in the experimental subjects [62]. Similarly, 12 weeks of the randomized controlled clinical study suggested that the Ecologic ® Barrier supplementation did not improve the lipid profile in T2D patients [63].…”

“…Studies based on the intervention of multi-genus, multi-species, multi-strain (strains of same species) probiotic preparation has been reported with positive effect on lipid profile [24][25][26]28,[31][32][33][34][36][37][38][39]47,48], while several studies reported no effect of multi-genus and multi-species probiotic intervention on the lipid profile [55][56][57][58][59][60][61][62][63]. Even though intervention of Ecologic ® Barrier (B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19 and W58) exhibit hypocholesterolemic effect on different subjects (individuals with T2D [38]; obese postmenopausal women [39]) with different intervention duration (six months [38]; 12 weeks [39]), dosage of probiotic mixture does not influence the cholesterol-lowering ability of the probiotic mixture.…”