← Back to Search

Probiotic

Active arm for Type 2 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
Awards & highlights

Study 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
  • Type 2 Diabetes

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c levels from baseline
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Bio-K Plus International Inc.Lead Sponsor
7 Previous Clinical Trials
1,321 Total Patients Enrolled
Montreal Heart InstituteOTHER
121 Previous Clinical Trials
68,789 Total Patients Enrolled
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
10,756 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population
2017. "A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03239366.
All > Type 2 Diabetes
~17 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top