Clinical trial NCT02274272: Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: lactobacillus reuteri
type 2 diabetes
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 86
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 type2 DM.

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 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).

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes with a duration\> 6 months
2. 7 % \< HbA1c ≦ 10 %
3. Adults 25- 70 years of age
4. BMI\>18.5

Exclusion Criteria:

1. Pregnancy
2. 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.
3. Autoimmune Disease
4. Administration of other healthy food for diabetes 4 weeks before inclusion
5. Administration of probiotic 4 weeks before inclusion
6. Administration of antibiotics 4 weeks before inclusion
7. Participation in other clinical trials
8. ALT/SGPT or AST/SGOT \> 3x upper limit of normal (ULN)
9. eGFR\<30mL/min/1.73m2
10. Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.

Primary outcomes:
measure: Change in blood sugar
timeFrame: 6 months
measure: Change in blood fat
timeFrame: 6 months
Secondary outcomes:
measure: Change in the DM marker
timeFrame: 6 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Genmont
Study officials:
affiliation: GenMont Biothech Incorporation
name: yi shing Chen, PhD
role: STUDY_DIRECTOR
References: