Effect of alive probiotic on insulin resistance in type 2 diabetes patients: Randomized clinical trial.

Abstract

BACKGROUND: Probiotics have beneficial effect on obesity related disorders in animal models. Despite a large number of animal data, randomized placebo-controlled trials (RCT) concluded that probiotics have a moderate effect on glycemic control-related parameters. However, effect of probiotics on insulin resistance are inconsistent.

AIM: In a double-blind single center RCT, effect of alive multistrain probiotic vs. placebo on insulin resistance in type 2 diabetes patient were assessed.

METHODS: A total of 53 patients met the criteria for inclusion. They were randomly assigned to receive multiprobiotic "Symbiter" (concentrated biomass of 14 probiotic bacteria genera Bifidobacterium, Lactobacillus, Lactococcus, Propionibacterium) or placebo for 8-weeks administered as a sachet formulation. The primary main outcome was the change HOMA-IR (homeostasis model assessment-estimated insulin resistance) which calculated using Matthews et al.'s equation. Secondary outcomes were the changes in glycemic control-related parameters, anthropomorphic variables and cytokines.

RESULTS: Supplementation with alive multiprobiotic for 8 weeks was associated with significant reduction of HOMA-IR from 6.85 ± 0.76 to 5.13 ± 0.49 (p = 0.047), but remained static in the placebo group. With respect to our secondary outcomes, HbA1c insignificant decreased by 0.09% (p = 0.383) and 0.24% (p = 0.068) respectively in placebo and probiotics groups. However, in probiotic responders (n = 22, patient with decrease in HOMA-IR) after supplementation a significant reduction in HbA1c by 0.39% (p = 0.022) as compared to non-responders was observed. In addition, from markers of chronic systemic inflammatory state only TNF-α and IL-1β changes significantly after treatment with probiotics.

CONCLUSION: Probiotic therapies modestly improved insulin resistance in patients with type 2 diabetes.