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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274272
• Other study ID #: P201404-31
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2014
• Last updated: October 10, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: GenMont Biotech Incorporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• ADR-1
two ADR-1 capsules, once daily, QD
• GMNL-263
two GMNL-263 capsules, once daily, QD
• placebo
two placebo capsules, once daily, QD

Locations

Country	Name	City	State
Taiwan	Genmont	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
GenMont Biotech Incorporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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