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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBS oral solution | Experimental | fermented soybean extract-MBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBS oral solution | Dietary Supplement | Oral BIDAC, twice a day before breakfast and dinner times |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4, 8,12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment changes from baseline in fasting plasma glucose at 12 weeks | 12 weeks post-treatment | |
| Post-treatment changes from baseline in HbA1c at 12 weeks | 12 weeks post-treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microbio Investigative Site | Taipei | 106 | Taiwan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Post-treatment changes from baseline in HOMA-IR at 12 weeks |
| 12 weeks post-treatment |
| Post-treatment changes from baseline in blood lipids composition at 12 weeks | Changes of triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) | 12 weeks post-treatment |
| Post-treatment changes from baseline in immune factors at 12 weeks | Changes of CRP, IL6, TNF-α expression | 12 weeks post-treatment |
| Incidence of treatment-emergent adverse events(TEAE) | 12 weeks post-treatment |