Type2 Diabetes Clinical Trial
Official title:
A Double-blind, Randomized Placebo Controlled Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population
This study will be conducted at the Montreal Heart Institute and should involve 130 Type 2 diabetes subjects. Subjects will be randomized in a 1:1 ratio to receive either Bio-K+50B® probiotic capsules or a matching placebo.
This is a phase 2 double-blind, randomized, single-center, placebo-controlled, parallel-group
12-week study of Bio-K+ probiotic 50B® in subjects diagnosed with Type 2 diabetes (T2D) and
suboptimal glycemic control.
After providing informed consent and completion of screening baseline assessments,
approximately 130 subjects will be randomized in a 1:1 ratio to receive either Bio-K+50B®
probiotic or matching placebo. Subjects will take investigational product or placebo once
daily orally for 12 weeks.
During the double-blind treatment period, subjects will complete a daily diary and will be
contacted via telephone (at Week 4 and Week 8) for an assessment of adverse events,
concomitant medications, diabetes management habits, collection of stool sample at home,
diary revision and study product compliance. At visit 3 (Week 12; end of study visit)
subjects will return to the study site for laboratory tests and clinical assessment.
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