Status:
COMPLETED
Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
Lead Sponsor:
GenMont Biotech Incorporation
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
25-70 years
Phase:
PHASE2
Brief Summary
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 ty...
Detailed Description
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 ef...
Eligibility Criteria
Inclusion
- Type 2 diabetes with a duration\> 6 months
- 7 % \< HbA1c ≦ 10 %
- Adults 25- 70 years of age
- BMI\>18.5
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT02274272
Start Date
October 1 2014
End Date
May 1 2017
Last Update
October 12 2017
Active Locations (1)
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1
Genmont
Tainan, Taiwan