NCT03239366

A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population

A Double-blind, Randomized Placebo Controlled Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Bio-K Plus International Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
OTHER	BioK+ 100% probiotic	The active BioK+ product will include the 3 strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®, representing the bacteria found in Bio-K+ probiotic capsules 50B®;
OTHER	Placebo	The placebo product will NOT include the 3 strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®, representing the bacteria found in Bio-K+ probiotic capsules 50B®;

Timeline

• Start date: 2017-09-06
• Primary completion: 2019-02-01
• Completion: 2019-06-01
• First posted: 2017-08-04
• Last updated: 2019-01-22

Locations

1 site across 1 country: Canada