A Phase 2 interventional study of ADR-1 and GMNL-263 in Type 2 Diabetes, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by GenMont Biotech Incorporation · Phase 2, Interventional, and Treatment
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).
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 86 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →GenMont Biotech Incorporation is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Other: placebo
Lactobacillus reuteri GMNL-89
Other: ADR-1
Lactobacillus reuteri GMNL-263
Other: GMNL-263
two ADR-1 capsules, once daily, QD
Also known as: Lactobacillus reuteri GMNL-89
two GMNL-263 capsules, once daily, QD
Also known as: Lactobacillus reuteri GMNL-263
two placebo capsules, once daily, QD
Change in blood sugar
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure blood sugar(mg/dL) and HbA1c(%).
Time frame: 6 months
Change in blood fat
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure cholesterol(mg/dL) ,triglycerides(TG, mg/dl), high density lipoprotein (HDL, mg/dl), low density lipoprotein (LDL, mg/dl).
Time frame: 6 months
Change in the DM marker
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure insulin(μIU/mL), C-peptide(ng/mL), Homeostasis model assessment for insulin resistance (HOMA-IR, ratio)
Time frame: 6 months
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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GenMont Biotech Incorporation