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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274272
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
GenMont Biotech Incorporation

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: ADR-1 Other: GMNL-263 Other: placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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 Name: Lactobacillus reuteri GMNL-89

Experimental: GMNL-263
Lactobacillus reuteri GMNL-263
Other: GMNL-263
two GMNL-263 capsules, once daily, QD
Other Name: Lactobacillus reuteri GMNL-263




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274272


Locations
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Taiwan
Genmont
Tainan, Taiwan
Sponsors and Collaborators
GenMont Biotech Incorporation
Investigators
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Study Director: yi shing Chen, PhD GenMont Biothech Incorporation

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Responsible Party: GenMont Biotech Incorporation
ClinicalTrials.gov Identifier: NCT02274272    
Other Study ID Numbers: P201404-31
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by GenMont Biotech Incorporation:
lactobacillus reuteri
type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases