Abstract
IntroductionType 1 diabetes mellitus (T1DM) is characterized by autoimmune destruction of pancreatic β cells. Previous study has discovered that probiotic strains residing in the gut play essential roles in host immune regulation. However, few clinical results demonstrated probiotic would actually benefit in attenuating glycated hemoglobin (HbA1c) along with inflammatory cytokine levels of the T1DM patients and analyzed their gut microbiota profile at the same time. In this clinical trial, we evaluated the therapeutic efficacy of probiotics on HbA1c along with inflammatory cytokine levels of T1DM patients to determine an alternative administration mode for T1DM medication. The probiotics changed T1DM gut microbiota profile will be measured by next-generation sequencing (NGS).Research Design and MethodsA randomized, double-blind, placebo-controlled trial was performed at China Medical University Hospital. T1DM patients between 6 and 18 years of age were enrolled. 27 patients were administered regular insulin therapy plus capsules containing probiotic strains Lactobacillus salivarius subsp. salicinius AP-32, L. johnsonii MH-68, and Bifidobacterium animalis subsp. lactis CP-9 daily for 6 months, and 29 patients were administered insulin therapy without extra probiotic supplement as placebo group. The variations of fasting blood glucose and HbA1c in these patients were analyzed. In addition, serum levels of inflammatory cytokines and anti-inflammatory cytokine were assessed using enzyme-linked immunosorbent assay. Patients’ stool microbiota were all subjects to NGS analysis.ResultsNGS data showed elevated populations of Bifidobacterium animalis, Akkermansia muciniphila and Lactobacillus salivarius in the gut of patients with T1DM who were taking probiotics. Patients with T1DM who were administered probiotics showed significantly reduced fasting blood glucose levels compared with the before-intervention levels. The HbA1c levels of the patients also improved after administration of probiotics. The concentrations of IL-8, IL-17, MIP-1β, RANTES, and TNF-α were significantly reduced and were associated with an increased TGF-β1 expression after probiotic intervention. The persistence effect of glycemic control and immunomodulation were observed even 3 months after discontinuation of the probiotics.ConclusionsHere, we found that conventional insulin therapy plus probiotics supplementation attenuated T1DM symptoms than receiving insulin treatment only. Probiotics supplementation with insulin treatment changed gut microbiota and revealed better outcome in stabilizing glycemic levels and reducing HbA1c levels in patients with T1DM through beneficial regulation of immune cytokines. Clinical Trial Registration ClinicalTrials.gov, identifier NCT03880760.
Highlights
Type 1 diabetes mellitus (T1DM) is characterized by autoimmune destruction of pancreatic b cells
Several studies have reported about the effects of probiotics on downregulation of glycemia in patients with T2DM; Asemi et al discovered that multispecies probiotics, namely L. acidophilus, L. rhamnosus, L. casei, L. bulgaricus, B. longum, and Streptococcus thermophilus could prevent the rise of fasting plasma glucose (FPG), reduce serum hs-C-reactive protein, and elevate plasma total glutathione in T2DM [33]
We revealed the ability of L. salivarius subsp. salicinius AP-32, L. johnsonii MH-68, and B. animalis subsp. lactis CP-9 to downregulate the immunerelated inflammatory cytokines IL-8, TNF-a, IL-17, MIP-1b, and RANTES and upregulate the anti-inflammatory cytokine TGF-b1 (Table 3 and Supplemental Figure S2)
Summary
Type 1 diabetes mellitus (T1DM) is characterized by autoimmune destruction of pancreatic b cells. Few clinical results demonstrated probiotic would benefit in attenuating glycated hemoglobin (HbA1c) along with inflammatory cytokine levels of the T1DM patients and analyzed their gut microbiota profile at the same time. In this clinical trial, we evaluated the therapeutic efficacy of probiotics on HbA1c along with inflammatory cytokine levels of T1DM patients to determine an alternative administration mode for T1DM medication. 27 patients were administered regular insulin therapy plus capsules containing probiotic strains Lactobacillus salivarius subsp. Type 1 diabetes mellitus (T1DM) is a chronic autoimmune disease, wherein pancreatic beta cells are attacked and disrupted by abnormal immune response [1]. Understanding the pathogenesis of T1DM and prevention of its onset are the main strategies in the investigation of this disease [8]
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