Clostridium Difficile InfectionPhase 4NCT01972932
Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea
A Phase 4 study testing Bio K+® 2 capsules orally (or via nasogastric tube) in people with Clostridium Difficile Infection and Antibiotic Associated Diarrhea, run by Bio-K Plus International Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Clostridium Difficile Infection, Antibiotic Associated Diarrhea
- What is being tested?
- Bio K+® 2 capsules orally (or via nasogastric tube)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Bio K+® 2 capsules orally (or via nasogastric tube), Placebo
- Keywords
- Bio-K+®, Placebo, AAD, CDI, hospitalized subjects
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio K+® 2 capsules orally (or via nasogastric tube)Dietary supplement
Also called 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.
PlaceboDietary supplement
Placebo Comparator: 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic. Receives: Dietary Supplement: Placebo |
| Bio K+® | Active comparator | Bio K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic. Receives: Dietary Supplement: Bio K+® 2 capsules orally (or via nasogastric tube) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Secondary outcomes (1)
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+®
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionAug 2017
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-K Plus International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhael Laskine, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Serge Carriere, MD, Study director, Bio-K+International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972932
- Sponsor's protocol ID
- CHUM 2014-5056
- Status last verified
- Jul 2022
- First submitted
- 25 Oct 2013
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01972932
- Acronym / sponsor ID
- CHUM 2014-5056
- Keywords
- Bio-K+®, Placebo, AAD, CDI, hospitalized subjects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bio-K Plus International Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic. |
| Bio K+® | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio K+® 2 capsules orally (or via nasogastric tube)Also: 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+® |
| PlaceboPlacebo Comparator: 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic. | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
To evaluate the incidence of antibiotic associated diarrhea
Time frame: 2 Years
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhael Laskine, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Serge Carriere, MD study director
Bio-K+International Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bio K+® 2 capsules orally (or via nasogastric tube) in people with Clostridium Difficile Infection and Antibiotic Associated Diarrhea, run by Bio-K Plus International Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence of Clostridium Difficile infection (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.