Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
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|ClinicalTrials.gov Identifier: NCT02274272|
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: ADR-1 Other: GMNL-263 Other: placebo||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||May 2017|
|Placebo Comparator: Placebo Capsules||
two placebo capsules, once daily, QD
Lactobacillus reuteri GMNL-89
two ADR-1 capsules, once daily, QD
Other Name: Lactobacillus reuteri GMNL-89
Lactobacillus reuteri GMNL-263
two GMNL-263 capsules, once daily, QD
Other Name: Lactobacillus reuteri GMNL-263
- Change in blood sugar [ Time Frame: 6 months ]Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure blood sugar(mg/dL) and HbA1c(%).
- Change in blood fat [ Time Frame: 6 months ]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).
- Change in the DM marker [ Time Frame: 6 months ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274272
|Study Director:||yi shing Chen, PhD||GenMont Biothech Incorporation|