Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: ADR-1
* Other: GMNL-263
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes with a duration> 6 months 7 % < HbA1c ≦ 10 % Adults 25- 70 years of age BMI>18.5 Exclusion Criteria: Pregnancy Subjects with any other serious diseases such as cancer (patient with benign tumor under medical control should not be ruled out), kidney failure / dialysis, heart disease, stroke. Autoimmune Disease Administration of other healthy food for diabetes 4 weeks before inclusion Administration of probiotic 4 weeks before inclusion Administration of antibiotics 4 weeks before inclusion Participation in other clinical trials ALT/SGPT or AST/SGOT > 3x upper limit of normal (ULN) eGFR<30mL/min/1.73m2 Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Capsules<br> | Other: placebo<br>* two placebo capsules, once daily, QD<br>|
| Experimental: ADR-1<br>Lactobacillus reuteri GMNL-89 | Other: ADR-1<br>* two ADR-1 capsules, once daily, QD<br>* Other names: Lactobacillus reuteri GMNL-89;|
| Experimental: GMNL-263<br>Lactobacillus reuteri GMNL-263 | Other: GMNL-263<br>* two GMNL-263 capsules, once daily, QD<br>* Other names: Lactobacillus reuteri GMNL-263;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, lactobacillus reuteri