Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Oct 2014
Longer than P75 for phase_2 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedOctober 12, 2017
October 1, 2017
2.5 years
October 8, 2014
October 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Change in the DM marker
6 months
Study Arms (3)
Placebo Capsules
PLACEBO COMPARATORADR-1
EXPERIMENTALLactobacillus reuteri GMNL-89
GMNL-263
EXPERIMENTALLactobacillus reuteri GMNL-263
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes with a duration\> 6 months
- % \< HbA1c ≦ 10 %
- Adults 25- 70 years of age
- BMI\>18.5
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Genmont
Tainan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
yi shing Chen, PhD
GenMont Biothech Incorporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 24, 2014
Study Start
October 1, 2014
Primary Completion
April 1, 2017
Study Completion
May 1, 2017
Last Updated
October 12, 2017
Record last verified: 2017-10