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

July 21, 2022 updated by: Bio-K Plus International Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The prevalence of Clostridium difficile infection (CDI) has been on the rise in the United States, and in fact the Centers for Disease Control and Prevention (CDC) identified CDI as one of the highest threats in its recent report on antibiotic resistance in the United States. This designation as an "urgent threat" highlights the need for immediate and aggressive action to prevent this infection.

In fact, CDI has been reported as the most commonly reported pathogen causing healthcare-associated infections (HAIs). A point prevalence survey of 183 hospitals in 10 states found that C. difficile comprised 12.1% of HAIs, surpassing Staphylococcus aureus infections.

Although most cases of CDI can be treated successfully with relatively safe and effective oral antibiotics (i.e., metronidazole or vancomycin), primary prevention of CDI is critical because up to one in five treated patients endures a relapse or reinfection, which can be difficult to treat; infected patients serve as a reservoir for ongoing transmission within facilities; implementation of contact isolation precautions for patients who have CDI can have deleterious consequences for the patient; and, CDI can result in death or severe disease including those treated by colectomy. Because CDI is spread between patients, prevention of a single case should reduce the risk of exposure for other hospital patients.

One of the main studies in this indication, being a quality improvement study conducted at Pierre Le Gardeur Hospital (PLGH) in province of Québec, Canada. Starting in 2004, 10 years of surveillance data were reported from this hospital that administers Bio-K Plus to all antibiotic users. During the 10 years of observation, 44, 835 inpatients received Bio-K+, and the CDI rate at PLGH declined from 18.0 cases per 10,000 patient-days and remained at low mean levels of 2.3 cases per 10 000 patient-days.

Additionally, 10-year data collected by the Ministry of Health in Quebec comparing the CDI rate between Quebec hospitals showed that CDI rates at PLGH were consistently and continuously lower compared with those at similar hospitals.

In conclusion, adding Bio-K Plus as a standard treatment led to a dramatic and sustained decrease in the incidence of C. difficile infections at this hospital.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Centre Hospitalier de L'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
Dietary supplement: Placebo
Placebo Comparator: 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
Active Comparator: Bio K+®
Bio K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic.
Dietary supplement: Bio K+® 2 capsules orally (or via nasogastric tube)
Bio-K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic.
Other Names:
  • Bio-K+®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the incidence of Clostridium Difficile infection
Time Frame: 2 Years
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.
2 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the incidence of antibiotic associated diarrhea
Time Frame: 2 Years
  • 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+®
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bio-K Plus International Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mikhael Laskine, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Study Director: Serge Carriere, MD, Bio-K+International Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUM 2014-5056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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