Back to resultsPostbiotic MBS and Metformin Combination in Patients With T2DM
Primary Purpose
Type-II Diabetes
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
MBS oral solution
Sponsored by
About this trial
This is an interventional treatment trial for Type-II Diabetes focused on measuring Diabetes Mellitus (DM), diabetes, T2DM, MBS, microbial
Eligibility Criteria
Inclusion Criteria:
- Male or female subject who aged from 20 to 70.
- BMI in between 18.5 and 35 kg/m2 inclusively.
- Fasting blood sugar ≥ 126 mg/dL, and confirmed diagnosis of type-II diabetes.
- 30 days prior to the screening visit (V1), HbA1c is steadily maintained in between 7-10% by medication.
- Prior to the screening visit (V1), subjects have been regularly taken 500-200 mg/day for at least 90 days.
Exclusion Criteria:
- Pregnant or breastfeeding women or female subjects plan to enter pregnancy during study period.
- Subjects who are allergic to soy or products containing it.
- At investigator's discretion, subjects are unlikely to comply with study procedures due to a history of alcohol or drug addiction.
- Subjects on vegetarian diet or other special diets (eg. Ketogenic or gluten-free diets).
- Subjects have ongoing participation in another clinical trial that involves the use of investigational drugs, medical devices, dietary supplements, and/or cosmetics.
- Subject with impaired renal function confirmed by Serum Total Bilirubin ≥ 1.5 upper limit of normal [ULN], Aspartate Transaminase/ Alanine Transaminase (AST/ALT) ≥ 2 ULN, Creatinine ≥ 2 ULN or eGFR <60 mL/min/1.73 m^2.
- Subjects who have been diagnosed with malignant tumors within five (5) years before the screening visit (V1) with exception to subjects with topical cancer but show significant recovery following investigator's assessment, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate or cervix or carcinoma in situ of the breast.
- 30 days prior to screening visit (V1), subjects have taken antibiotics, synthetic drugs (Sulfonamides, Fluoroquinolone, etc.), anti-fungal or anti-viral medication but not limited to topical forms for use in skin application.
- Within 14 days prior to screening visit (V1), subjects have taken products or supplements that contain probiotics or prebiotics.
- Within 14 days prior to screening visit (V1), subjects experience diarrhea caused by gastrointestinal infection (3 times of watery stool within 24 hours).
- Within14 days prior to screening visit (V1), subjects have taken steroids, immunosuppressant, and/or inflammatory medicines.
- Subjects took or intend to take medications other than metformin that may affect intestinal flora within 30 days prior to screening visit, during screening period or whole trial period. Examples of this kind of medication include DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, hypoglycemic sulfonamides, thiazolidinediones, SGLT2 inhibitors, and insulin.
Sites / Locations
- Microbio Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MBS oral solution
Arm Description
fermented soybean extract-MBS
Outcomes
Primary Outcome Measures
Post-treatment changes of intestinal flora
Post-treatment changes from baseline in microbial composition, abundance, variation of subject's intestinal flora at 4, 8, 12 weeks.
Secondary Outcome Measures
Post-treatment changes from baseline in fasting plasma glucose at 12 weeks
Post-treatment changes from baseline in HbA1c at 12 weeks
Post-treatment changes from baseline in HOMA-IR at 12 weeks
Post-treatment changes from baseline in blood lipids composition at 12 weeks
Changes of triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
Post-treatment changes from baseline in immune factors at 12 weeks
Changes of CRP, IL6, TNF-α expression
Incidence of treatment-emergent adverse events(TEAE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04639492
Brief Title
Postbiotic MBS and Metformin Combination in Patients With T2DM
Official Title
Evaluating the Effect and Safety of Postbiotic MBS and Metformin Combination on Gut Microbiota and Symptom in Patients With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microbio Co Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin. The scientific data collected will be referenced for future product development.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-II Diabetes
Keywords
Diabetes Mellitus (DM), diabetes, T2DM, MBS, microbial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBS oral solution
Arm Type
Experimental
Arm Description
fermented soybean extract-MBS
Intervention Type
Dietary Supplement
Intervention Name(s)
MBS oral solution
Intervention Description
Oral BIDAC, twice a day before breakfast and dinner times
Primary Outcome Measure Information:
Title
Post-treatment changes of intestinal flora
Description
Post-treatment changes from baseline in microbial composition, abundance, variation of subject's intestinal flora at 4, 8, 12 weeks.
Time Frame
4, 8,12 weeks post-treatment
Secondary Outcome Measure Information:
Title
Post-treatment changes from baseline in fasting plasma glucose at 12 weeks
Time Frame
12 weeks post-treatment
Title
Post-treatment changes from baseline in HbA1c at 12 weeks
Time Frame
12 weeks post-treatment
Title
Post-treatment changes from baseline in HOMA-IR at 12 weeks
Time Frame
12 weeks post-treatment
Title
Post-treatment changes from baseline in blood lipids composition at 12 weeks
Description
Changes of triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
Time Frame
12 weeks post-treatment
Title
Post-treatment changes from baseline in immune factors at 12 weeks
Description
Changes of CRP, IL6, TNF-α expression
Time Frame
12 weeks post-treatment
Title
Incidence of treatment-emergent adverse events(TEAE)
Time Frame
12 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subject who aged from 20 to 70.
BMI in between 18.5 and 35 kg/m2 inclusively.
Fasting blood sugar ≥ 126 mg/dL, and confirmed diagnosis of type-II diabetes.
30 days prior to the screening visit (V1), HbA1c is steadily maintained in between 7-10% by medication.
Prior to the screening visit (V1), subjects have been regularly taken 500-200 mg/day for at least 90 days.
Exclusion Criteria:
Pregnant or breastfeeding women or female subjects plan to enter pregnancy during study period.
Subjects who are allergic to soy or products containing it.
At investigator's discretion, subjects are unlikely to comply with study procedures due to a history of alcohol or drug addiction.
Subjects on vegetarian diet or other special diets (eg. Ketogenic or gluten-free diets).
Subjects have ongoing participation in another clinical trial that involves the use of investigational drugs, medical devices, dietary supplements, and/or cosmetics.
Subject with impaired renal function confirmed by Serum Total Bilirubin ≥ 1.5 upper limit of normal [ULN], Aspartate Transaminase/ Alanine Transaminase (AST/ALT) ≥ 2 ULN, Creatinine ≥ 2 ULN or eGFR <60 mL/min/1.73 m^2.
Subjects who have been diagnosed with malignant tumors within five (5) years before the screening visit (V1) with exception to subjects with topical cancer but show significant recovery following investigator's assessment, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate or cervix or carcinoma in situ of the breast.
30 days prior to screening visit (V1), subjects have taken antibiotics, synthetic drugs (Sulfonamides, Fluoroquinolone, etc.), anti-fungal or anti-viral medication but not limited to topical forms for use in skin application.
Within 14 days prior to screening visit (V1), subjects have taken products or supplements that contain probiotics or prebiotics.
Within 14 days prior to screening visit (V1), subjects experience diarrhea caused by gastrointestinal infection (3 times of watery stool within 24 hours).
Within14 days prior to screening visit (V1), subjects have taken steroids, immunosuppressant, and/or inflammatory medicines.
Subjects took or intend to take medications other than metformin that may affect intestinal flora within 30 days prior to screening visit, during screening period or whole trial period. Examples of this kind of medication include DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, hypoglycemic sulfonamides, thiazolidinediones, SGLT2 inhibitors, and insulin.
Facility Information:
Facility Name
Microbio Investigative Site
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
12. IPD Sharing Statement
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Postbiotic MBS and Metformin Combination in Patients With T2DM
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