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

NCT ID: NCT02274272

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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).

Conditions

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Type 2 Diabetes

Keywords

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lactobacillus reuteri type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

two placebo capsules, once daily, QD

ADR-1

Lactobacillus reuteri GMNL-89

Group Type EXPERIMENTAL

ADR-1

Intervention Type OTHER

two ADR-1 capsules, once daily, QD

GMNL-263

Lactobacillus reuteri GMNL-263

Group Type EXPERIMENTAL

GMNL-263

Intervention Type OTHER

two GMNL-263 capsules, once daily, QD

Interventions

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ADR-1

two ADR-1 capsules, once daily, QD

Intervention Type OTHER

GMNL-263

two GMNL-263 capsules, once daily, QD

Intervention Type OTHER

placebo

two placebo capsules, once daily, QD

Intervention Type OTHER

Other Intervention Names

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Lactobacillus reuteri GMNL-89 Lactobacillus reuteri GMNL-263

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GenMont Biotech Incorporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yi shing Chen, PhD

Role: STUDY_DIRECTOR

GenMont Biothech Incorporation

Locations

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Genmont

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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P201404-31

Identifier Type: -

Identifier Source: org_study_id