Active arm for Diabetes

Phase 2

Waitlist Available

Led By Jean Claude Tardif, MD

Research Sponsored by Bio-K Plus International Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

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.

Eligible Conditions

Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c levels from baseline

Secondary study objectives

Evaluation of the effects of Bio-K+50B® as compared with placebo after 12 weeks of treatment on different biochemical markers

Evaluation of the intestinal colonisation effects with the 2 capsules of Bio-K+50B® (dosage of 100 billions bacterias) as compared with placebo

Evaluation of the safety profile of 2 capsules of Bio-K+50B® (dosage of 100 billions bacterias)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active armActive Control1 Intervention

Active product 'BioK+ 100% probiotic: Bio-K+50B® probiotic will be administered orally for a period of 12 weeks. Dose: two (2) capsules of 50 billion (B) colony forming units (CFU) providing a dosage of 100 billion CFU per day

Group II: Placebo armPlacebo Group1 Intervention

Placebo product (without the 3 strains of bacterias) will be administered orally for a period of 12 weeks. Dose: Two (2) capsules of Placebo per day

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