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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: placebo; Other: ADR-1; Other: GMNL-263

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).

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Genmont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GenMont Biotech Incorporation
• Investigators: Study Director: yi shing Chen, PhD, GenMont Biothech Incorporation

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: type 2 diabetes; lactobacillus reuteri
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: P201404-31