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

Primary Purpose

Clostridium Difficile Infection, Antibiotic Associated Diarrhea

Status

Terminated

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Bio K+® 2 capsules orally (or via nasogastric tube)

Placebo

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring Bio-K+®, Placebo, AAD, CDI, hospitalized subjects

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Bio K+®

Arm Description

Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

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

Outcomes

Primary Outcome Measures

To evaluate the incidence of Clostridium Difficile infection

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

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+®

Full Information

NCT ID

NCT01972932

First Posted

October 25, 2013

Last Updated

July 21, 2022

Sponsor

Bio-K Plus International Inc.

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

1. Study Identification

Unique Protocol Identification Number

NCT01972932

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Recruitment problems

Study Start Date

November 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bio-K Plus International Inc.

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile Infection, Antibiotic Associated Diarrhea

Keywords

Bio-K+®, Placebo, AAD, CDI, hospitalized subjects

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

Arm Title

Bio K+®

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Bio K+® 2 capsules orally (or via nasogastric tube)

Other Intervention Name(s)

Bio-K+®

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo Comparator: 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

Primary Outcome Measure Information:

Title

To evaluate the incidence of Clostridium Difficile infection

Description

Time Frame

2 Years

Secondary Outcome Measure Information:

Title

To evaluate the incidence of antibiotic associated diarrhea

Description

Time Frame

2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mikhael Laskine, MD

Organizational Affiliation

Centre hospitalier de l'Université de Montréal (CHUM)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Serge Carriere, MD

Organizational Affiliation

Bio-K+International Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Centre Hospitalier de l'Université de Montréal

City

Montreal

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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