| Summary: | It has been shown that gut dysbiosis can be associated with the development of type 2 diabetes mellitus (T2DM). Consequently, intervention with probiotics may be a useful approach to improve metabolic variables in diabetes. The present study aimed to evaluate the efficacy of <i>L. paracasei</i> HII01 on glycemia in T2DM patients. In a randomized, double-blind, placebo-controlled study, 50 participants were allocated to receive <i>L. paracasei</i> HII01 (50 × 10<sup>9</sup> CFU/day) or a placebo (corn starch 10 mg/day). Blood and fecal samples were assessed at baseline and at the end of the trial. After 12 weeks of intervention, fasting blood glucose level had significantly decreased in the probiotic group compared with the placebo group. Importantly, probiotic supplementation significantly decreased the plasma levels of LPS, TNF-α, IL-6 and hsCRP compared the placebo group. Additionally, an increase in beneficial bacteria and a decrease in pathogenic bacteria, which related to the improvement of SCFAs, was found following <i>L. paracasei</i> HII01 supplementation. These findings demonstrated that <i>L. paracasei</i> HII01 improved hyperglycemia and inflammatory markers by favorably modifying gut microbiota and subsequently ameliorating the leaky gut and endotoxemia, thereby suggesting a potential role as an adjuvant treatment in type 2 diabetes.
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