Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2025-12-24 @ 4:06 PM
NCT ID:
NCT03239366
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT03239366
Study Brief:
Protocol Section:
NCT03239366