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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Oral BIDAC, twice a day before breakfast and dinner times
Microbio Investigative Site
Taipei, Taiwan
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.
Time frame: 4, 8,12 weeks post-treatment
Post-treatment changes from baseline in fasting plasma glucose at 12 weeks
Time frame: 12 weeks post-treatment
Post-treatment changes from baseline in HbA1c at 12 weeks
Time frame: 12 weeks post-treatment
Post-treatment changes from baseline in HOMA-IR at 12 weeks
Time frame: 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)
Time frame: 12 weeks post-treatment
Post-treatment changes from baseline in immune factors at 12 weeks
Changes of CRP, IL6, TNF-α expression
Time frame: 12 weeks post-treatment
Incidence of treatment-emergent adverse events(TEAE)
Time frame: 12 weeks post-treatment
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