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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Capsules | Placebo Comparator |
| |
| ADR-1 | Experimental | Lactobacillus reuteri GMNL-89 |
|
| GMNL-263 | Experimental | Lactobacillus reuteri GMNL-263 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADR-1 | Other | two ADR-1 capsules, once daily, QD |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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(%). | 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yi shing Chen, PhD | GenMont Biothech Incorporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genmont | Tainan | Taiwan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| GMNL-263 | Other | two GMNL-263 capsules, once daily, QD |
|
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| placebo | Other | two placebo capsules, once daily, QD |
|
| D004700 | Endocrine System Diseases |