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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Active arm

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 Type ACTIVE_COMPARATOR

BioK+ 100% probiotic

Intervention Type 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®;

Placebo arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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®;

Interventions

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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®;

Intervention Type 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®;

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* A patient who meets any of the following criteria will NOT be eligible to the study:

1. Subjects unlikely to cooperate in the study;
2. Legal incapacity or limited legal capacity;
3. 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:

1. Have had a hysterectomy or tubal ligation prior to Visit 1.
2. 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.
4. 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;
5. Type 1 diabetes;
6. Gestational diabetes;
7. 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),
* Infections (Congenital rubella, Cytomegalovirus, coxsackie);
* Genetic syndromes associated with diabetes (Down's syndrome, Klinefleter's syndrome, Turner's syndrome);
8. Subjects whose medication for glycemic control has been changed in the past 3 months or whose medication is likely to be changed during the conduct of the study;
9. Chronic gastro-intestinal illness (e.g. Crohn's disease, ulcerative colitis, colon cancer);
10. Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes;
11. Current treatment with nasogastric tube, ostomy, or parenteral nutrition;
12. Immunodeficiency;
13. Morbid obesity, as evidenced by Body Mass Index (BMI) ≥ 40;
14. Eating disorder;
15. Uncontrolled mental illness that could interfere with the conduct of the study;
16. Known pancreatic disease, other than diabetes mellitus;
17. Known severe renal disease (creatinine ≥200 micromoles per liter);
18. Known moderate or severe liver disease (enzymes alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 times upper normal limit);
19. Significant anemia defined as blood hemoglobin lower than 110 grams per liter (in males) or lower than 100 grams per liter (in females);
20. History of alcohol, medication or drug abuse;
21. History of smoking in the past 12 months;
22. Daily consumption of prebiotics and/or probiotics;
23. Daily consumption of fermented milk (more than 1 litre a day);
24. Known allergies to any substance in the study product or placebo;
25. Any serious disease likely to interfere with the conduct of the study or compromise subject safety;
26. Life expectancy shorter than 6 months;
27. Subjects requiring treatments which will not be tolerated in this study (refer to Appendix 2);
28. Lactose intolerance or allergy to cow's milk protein;
29. Any condition or therapy that the investigator believes might pose a risk to the patient or make participation in the study not in the patient's best interest; Chronic and regular usage of anti-inflammatory drugs and recent use (in the last three months) of oral antibiotics will not be tolerated in the context of this study because of their well-recognized modifying effect of the intestinal flora;
30. Known heart failure and/or left ventricular ejection fraction less than 30%;
31. Insulin therapy;
32. Taking a natural health product that may affect blood glucose levels such as chromium, cinnamon bark, or bitter melon product.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No