Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea

This study has been terminated.
Sponsor:
Collaborator:
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by (Responsible Party):
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT01972932
First received: October 25, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI) are the most common causes of healthcare associated infectious diarrhea. In light of the results obtained in a limited number of randomized clinical trials in subjects with AAD and CDI in comparison with the widespread occurrence of these diseases, it is felt that the addition of a well-controlled clinical trial in a western environment would add value to support the use of a specific probiotic to counteract these diseases.


Condition Intervention Phase
Clostridium Difficile Infection
Antibiotic Associated Diarrhea
Dietary Supplement: Bio-K®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Protocol CHUM 2014-5056: A Randomized, Double Blinded Placebo Controlled Study to Evaluate the Efficacy of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:
  • To evaluate the incidence of Clostridium Difficile infection [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The primary objective of this study is evaluate the incidence risk ratio of CDI in hospitalized subjects treated with systemic antibiotics, taking oral administration of Bio-K+® in comparison with a placebo. Risk will be calculated for the period of antibiotic treatment plus 65 days.


Secondary Outcome Measures:
  • To evaluate the incidence of antibiotic associated diarrhea [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    • To evaluate the incidence of AAD
    • To evaluate the incidence of RCDI
    • To determine the time to occurrence of the first symptoms (first liquid stool) of AAD or CDI -
    • To evaluate the impact on the duration of hospitalization
    • To evaluate the number of emergency room visits and re-hospitalizations for AAD or CDI
    • To determine the mean costs for the initial hospitalization
    • To evaluate the safety profile of Bio-K+®


Estimated Enrollment: 800
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2 capsules orally (or via nasogastric tube)
Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
Experimental: Bio K+® 2 capsules orally (or via nasogastric tube)

Subjects who meet all inclusion/exclusion criteria will be randomized to one of the following study arms: Bio K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic. Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

Assignment to the study arms will be based on a computer-generated randomization schedule prepared by a statistician before the start of the study. Subjects will be randomized in blocks of six (3 in each group), stratified by service (internal medicine, pneumology, cardiac surgery and vascular surgery). Blocks will be independent for each Hospital to ensure optimal randomization.

Dietary Supplement: Bio-K®

2 ARMS STUDY

  • Bio-K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic.
  • Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
Other Name: Bio-K®

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Only subjects who meet the following inclusion criteria will be eligible to participate in the study:

  • Are at least 18 years old
  • Able to tolerate food intake Antibiotic treatment started less than 48hrs from admission into the study
  • Have an expected hospitalization period of at least three days (including subject‟s stay in the emergency room)
  • Speak and understand English and/or French.
  • Have an expected survival greater than 60 days
  • Agree to refrain from taking probiotic products (besides the study drug) during the study period Have given informed consent In addition, women of child bearing capacity who are not pregnant at the moment of screening (pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed to participate.

Exclusion Criteria

Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:

  • Have been diagnosed with CDI in previous sixty days
  • Have taken Streptomycin, oral Vancomycin, or Metronidazole in the last 4 weeks, excluding as part of the treatment regimen triggering their inclusion into the study.
  • Are currently suffering from any health condition causing immunosuppression (including haematological malignancies, lymphoma, AIDS, transplant, and hemodialysis)
  • Have received more than 10 mg of prednisone per day for at least 1 month within 3 months prior to the participation to the study.
  • Have active diarrhea (three or more liquid stools per 24 hour period) or non-controlled intestinal disease/colitis such as Crohn's disease, ulcerative colitis or caeliac disease Have stomas, are ostomized or are parenteral nutrition users Have already been randomized to one arm of this study
  • Are known to have shown a previous reaction, including anaphylaxis, to any substance in the composition of the study products (i.e. Non-medicinal ingredients: Cellulose, hypromellose, medium chain triglycerides, sodium alginate, ascorbic acid, magnesium stearate (vegetal source), silicon dioxide and titanium dioxide
  • Where receiving systemic antibiotics on admission to the hospital or who have been treated with antibiotics over the past two weeks Have lactose intolerance or milk allergy
  • Have difficulties giving informed consent because of chronic mental disease, dementia
  • Are not likely to comply with study requirements (provide stool for screening if diarrhea or answer to the follow up questionnaires)
  • Have been known to use illicit drugs in the last two years. Have participated in another clinical study in the last 30 days
  • Female subjects that are pregnant, or who intend to become pregnant or are lactating during the study period
  • Female subjects of child bearing potential not currently using adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972932

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Sponsors and Collaborators
Bio-K Plus International Inc.
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Mikhael Laskine, MD Centre Hospitalier de l'Université de Montréal
Study Director: Serge Carriere, MD Bio-K+International Inc.
  More Information

No publications provided

Responsible Party: Bio-K Plus International Inc.
ClinicalTrials.gov Identifier: NCT01972932     History of Changes
Other Study ID Numbers: CHUM 2014-5056
Study First Received: October 25, 2013
Last Updated: June 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by Bio-K Plus International Inc.:
Bio-K+®
Placebo
AAD
CDI
hospitalized subjects

Additional relevant MeSH terms:
Diarrhea
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 20, 2014