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

NCT03239366 | Unknown Phase 2 DMC

• 1 other identifier: ProbioHeart 2017.18
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

T2D

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c levels from baseline

  The primary objective is to evaluate the effect of Bio-K+50B® on HbA1c level compared with placebo after 12 weeks of treatment in subjects with T2D and suboptimal glycemic control (HbA1c \>7% at baseline).

  12 weeks

Secondary Outcomes (3)

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (2)

Active arm

ACTIVE COMPARATOR

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

Other: BioK+ 100% probiotic

Placebo arm

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

BioK+ 100% probiotic OTHER

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®;

Active arm

Placebo OTHER

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®;

Placebo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older on the day of consent;
• T2D diagnosis according to Canadian diabetes guidelines\[24\] and treated with medication for this diagnosis;
• Suboptimal glycemic control, as evidenced by HbA1c \>7%;
• Body Mass Index (BMI); greater than or equal to 25 and less than 40 kg/m2
• Subjects willing to maintain a stable diet and physical activity level throughout the study;
• Ability and willingness to give written informed consent and to comply with the requirements of the study.
• The subject is able to read and write English or French.

You may not qualify if:

• A patient who meets any of the following criteria will NOT be eligible to the study:
• Subjects unlikely to cooperate in the study;
• Legal incapacity or limited legal capacity;
• Women who are pregnant, planning to become pregnant during the study or breast-feeding. Women of childbearing potential must have a negative urine pregnancy test at screening. Women are considered not of childbearing potential if they:
• Have had a hysterectomy or tubal ligation prior to Visit 1.
• Are postmenopausal defined as no menses for 12 months or a Follicle-stimulating Hormone (FSH) level in the menopausal range.
• Women of childbearing potential must agree to use an effective method of birth control throughout the study. Acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide or cervical cap, abstinence, or a sterile sexual partner.
• Participation in a drug or device trial within the previous 30 days (or within 5 half-lives of the investigational drug, or within the time legally required by local regulatory authorities, whichever is the longest) or participation in such trial considered, or patient already enrolled in the study. Participation to observation registries is allowed;
• Type 1 diabetes;
• Gestational diabetes;
• Diabetes secondary to:
• Genetic defects of beta (β) cell function (Maturity-Onset Diabetes of the Young) or insulin action;
• Diseases of the exocrine pancreas (pancreatitis, neoplasia, cystic fibrosis, hemochromatosis);
• Endocrinopathies (Acromegaly, Cushing's syndrome, glucagonoma, pheochromocytome, hyperthyroidism);
• Drugs (glucocorticoids, clozapine),

Sponsors & Collaborators

• Bio-K Plus International Inc.: lead
• Montreal Heart Institute: collaborator
• The Montreal Health Innovations Coordinating Center (MHICC): collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

RECRUITING

Related Publications (3)

• Tonucci LB, Olbrich Dos Santos KM, Licursi de Oliveira L, Rocha Ribeiro SM, Duarte Martino HS. Clinical application of probiotics in type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled study. Clin Nutr. 2017 Feb;36(1):85-92. doi: 10.1016/j.clnu.2015.11.011. Epub 2015 Dec 7.

  PMID: 26732026 RESULT

• Ferguson JF, Allayee H, Gerszten RE, Ideraabdullah F, Kris-Etherton PM, Ordovas JM, Rimm EB, Wang TJ, Bennett BJ; American Heart Association Council on Functional Genomics and Translational Biology, Council on Epidemiology and Prevention, and Stroke Council. Nutrigenomics, the Microbiome, and Gene-Environment Interactions: New Directions in Cardiovascular Disease Research, Prevention, and Treatment: A Scientific Statement From the American Heart Association. Circ Cardiovasc Genet. 2016 Jun;9(3):291-313. doi: 10.1161/HCG.0000000000000030. Epub 2016 Apr 19.

  PMID: 27095829 RESULT

• Cuthill S, Muroke V, Dubois A, Dube MP, Guertin MC, Millette M, Tardif JC. Effect of probiotic supplementation on glycemic control in patients with type 2 diabetes: A randomized controlled trial. Clin Nutr ESPEN. 2025 Aug;68:148-152. doi: 10.1016/j.clnesp.2025.05.013. Epub 2025 May 7.

  PMID: 40345656 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jean Claude Tardif, MD

  Cardiologist at the MHI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle de Montigny, M.Sc.

CONTACT

450-978-2465; ddemontigny@biokplus.com

Serge Carrière, MD

CONTACT

450-978-2465; scarriere@biokplus.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double blind, randomized and placebo controlled. The clinical and operational teams from both MHI and BioK+ are blinded. Treatment codes will be available at the research pharmacy from the MHI.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will evaluate the effects of Bio-K+50B® at a dosage of 100 billion (B) colony forming units (CFU) daily for 12 weeks in improving glycemic control in patients with Type 2 diabetes (T2D) population when compared to placebo.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 4, 2017
• Study Start: September 6, 2017
• Primary Completion: February 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)