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Completed

NCT Number: NCT02274272

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Genmont

Tainan, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

ADR-1

Other

two ADR-1 capsules, once daily, QD

Other names: Lactobacillus reuteri GMNL-89

GMNL-263

Other

two GMNL-263 capsules, once daily, QD

Other names: Lactobacillus reuteri GMNL-263

Placebo

Other

two placebo capsules, once daily, QD

Primary outcomes

  1. Change in blood sugar

    Time frame: 6 months

    Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure blood sugar(mg/dL) and HbA1c(%).

  2. Change in blood fat

    Time frame: 6 months

    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).

Secondary outcomes

  1. Change in the DM marker

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

GenMont Biotech Incorporation

Industry

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2014
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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