Type 2 Diabetes Clinical Trial
The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263 capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of adults with type2 DM.
Background：Based on animal studies, intake of probiotic bacteria was suggested to improve
insulin sensitivity by reducing inflammation.
Objective ： The objective of this study was to determine the effects of supplementation with
the probiotic strain Lactobacillus reuteri ADR-1(ADR-1) and Lactobacillus reuteri GMNL-263
(GMNL-263) over six months on metabolic profiles, intestinal microbiota profiles and
biomarkers of inflammation in type 2 diabetes patents. Methods ： This randomized double-blind
placebo-controlled clinical trial was performed on 120 diabetic patients. Subjects were
divided into 3 groups: 40 subjects in the group A received placebo, 40 subjects in the group
B received ADR-1 (4 x 109 colony-forming units/d), and 40 subjects in the group C received
GMNL-263. (2 x 1010 cells/d) for 6 months. Fasting blood samples were taken at baseline and
after intervention to measure metabolic profiles and biomarkers of inflammation including C
reactive protein (CRP), Interleukin 6 (IL-6) and Tumor necrosis factor-alpha( TNF-α). The
intestinal microbiota profiles were detected in stool samples by real-time polymerase chain
reaction (RT-PCR).
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