DiarrheaPhase 3NCT00328263
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
A Phase 3 study testing Lactobacillus acidophilus CL1285 and Lactobacillus casei in people with Diarrhea and Clostridium Infections, run by Bio-K Plus International Inc. at 8 sites in Canada.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea, Clostridium Infections
- What is being tested?
- Lactobacillus acidophilus CL1285 and Lactobacillus casei
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 8 sitesCanada
- Study dates
- Mar 2006to Oct 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presenting to the Emergency Room and considered for admission to hospital for a minimum of 12 hours and requiring antibiotic administration for the treatment of a suspected or proven bacterial infection OR a hospitalized patient developing a suspected or proven nosocomial infection OR an external patient that come to the hospital for repeated visits to receive his intravenous antibiotic therapy for the treatment of a suspected or proven bacterial infection. The external patients on oral antibiotics that come to the hospital for repeated visits to receive any other treatments requiring a hospital stay of more than one hour will also be included.
- Hospital employee on antibiotics can also be included in the study
- having received less than 24 hours of antibiotic therapy;
- requiring a minimum of 3 days and a maximum of 14 days antibiotic administration
- Informed consent must be obtained in writing for all subjects at enrollment into the study
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- active diarrhea;
- a history of daily consumption of fermented milk and/or yogurt;
- intolerance to lactose;
- pregnant/breastfeeding women;
- an active, non controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
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- ileostomy, jejunostomy or colostomy;
- immunosuppressed state;
- a previous documented C. difficile infection in the three months prior to study initiation;
- active radiotherapy or chemotherapy;
- recent (< 6 months) or planned bone marrow graft or organ transplant;
- antibiotic therapy in the fourteen days prior to study initiation;
- the planned administration of metronidazole (alone or in combination) or vancomycin monotherapy for the treatment of an infection;
- mental or other conditions, or language barriers rendering the subject unable to understand the nature, scope, and possible consequences of the study or complete the self-administered questionnaires;
- subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Post-enrollment exclusion criteria include fermented milk and/or yogurt consumption during the study period and two consecutive missed dose of study product.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Hotel Dieu de Chicoutimi
Chicoutimi, Quebec, G7H5H6
Hamilton General Hospital
Hamilton, Ontario, L8L-2X2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St-Mary Hospital Center
Montreal, Quebec, H3T 1M5
Laval Hospital
Québec, Quebec, G1V 4G5
Hotel-Dieu de St-Jerome
Saint-Jérôme, Quebec, J7Z 5T3
North York General Hospital
Toronto, Ontario, M2K 1E1
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9
About this study
Official title: A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy and Safety of BIO-K*+ CL-1285* in the Prevention of Antibiotic-associated Diarrhea in Adult Patients Exposed to Nosocomial Infection.
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
Read the detailed description
Antibiotic-associated diarrhea (AAD) is one of the most frequent adverse events following antibiotherapy and is the leading cause of diarrhea in hospitalized patients. Ten to 25% of AAD are caused by the bacteria Clostridium difficile.
A recent unicenter study conducted at Maisonneuve-Rosemont hospital demonstrated the preventive role of Bio-K + CL1285 in antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea. Its preventive role is thought to be mainly through restoration of the gastrointestinal flora affected in part by the antibiotherapy.
A wide body of literature reveals clinical use of probiotics, but few well controlled prospective studies conducted on large numbers of subjects have been performed.
In light of the positive preliminary results obtained in a limited number of patients with AAD and of the paucity of well controlled clinical trials, we now wish to undertake a randomized, double blind, multicentre study to evaluate the efficacy and safety of Bio-K + CL1285 prophylaxis vs. placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients. As secondary objectives, we also intend to evaluate the incidence of Clostridium difficile-associated diarrhea and to demonstrate that BIO-K + CL1285 agent will not only improve the clinical outcomes but also reduce health care expenditures.
- Conditions
- Diarrhea, Clostridium Infections
- Being tested
- Lactobacillus acidophilus CL1285 and Lactobacillus casei, placebo
- Keywords
- Bio-K+CL1285, Probiotics, Antibiotics-associated diarrhea, Clostridium difficile-associated diarrhea, Lactobacillus acidophilus, Clostridium Difficile
- Medical subject headings
- Diarrhea, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilus CL1285 and Lactobacillus caseiDietary supplement
Also called BioK CL1285
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
placeboDietary supplement
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria. Receives: Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei |
| 2 | Placebo comparator | placebo devoid of bacteria Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Antibiotic-associated Diarrhea.
Presence of at least one diarrhea episode within 24 hours.
Measured: Up to 40 days
Secondary outcomes (3)
Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.
Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.
Measured: Up to 40 days
Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
Measured: Up to 40 days
Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics
Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiarrheaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-K Plus International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Responsible party
- Sponsor
- Investigators
- Joe S Dylewski, MD, Principal investigator, St-Mary Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328263
- Sponsor's protocol ID
- CL1285-AAD-M01
- Status last verified
- Jul 2014
- First submitted
- 17 May 2006
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy and Safety of BIO-K*+ CL-1285* in the Prevention of Antibiotic-associated Diarrhea in Adult Patients Exposed to Nosocomial Infection.
- ClinicalTrials.gov ID
- NCT00328263
- Acronym / sponsor ID
- CL1285-AAD-M01
- Conditions
- Diarrhea, Clostridium Infections
- Keywords
- Bio-K+CL1285, Probiotics, Antibiotics-associated diarrhea, Clostridium difficile-associated diarrhea, Lactobacillus acidophilus, Clostridium Difficile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Bio-K Plus International Inc.Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
Detailed description
Antibiotic-associated diarrhea (AAD) is one of the most frequent adverse events following antibiotherapy and is the leading cause of diarrhea in hospitalized patients. Ten to 25% of AAD are caused by the bacteria Clostridium difficile.
A recent unicenter study conducted at Maisonneuve-Rosemont hospital demonstrated the preventive role of Bio-K + CL1285 in antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea. Its preventive role is thought to be mainly through restoration of the gastrointestinal flora affected in part by the antibiotherapy.
A wide body of literature reveals clinical use of probiotics, but few well controlled prospective studies conducted on large numbers of subjects have been performed.
In light of the positive preliminary results obtained in a limited number of patients with AAD and of the paucity of well controlled clinical trials, we now wish to undertake a randomized, double blind, multicentre study to evaluate the efficacy and safety of Bio-K + CL1285 prophylaxis vs. placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients. As secondary objectives, we also intend to evaluate the incidence of Clostridium difficile-associated diarrhea and to demonstrate that BIO-K + CL1285 agent will not only improve the clinical outcomes but also reduce health care expenditures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus caseiBio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria. |
| 2 | Placebo comparator | Dietary Supplement: placeboplacebo devoid of bacteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- presenting to the Emergency Room and considered for admission to hospital for a minimum of 12 hours and requiring antibiotic administration for the treatment of a suspected or proven bacterial infection OR a hospitalized patient developing a suspected or proven nosocomial infection OR an external patient that come to the hospital for repeated visits to receive his intravenous antibiotic therapy for the treatment of a suspected or proven bacterial infection. The external patients on oral antibiotics that come to the hospital for repeated visits to receive any other treatments requiring a hospital stay of more than one hour will also be included.
- Hospital employee on antibiotics can also be included in the study
- having received less than 24 hours of antibiotic therapy;
- requiring a minimum of 3 days and a maximum of 14 days antibiotic administration
- Informed consent must be obtained in writing for all subjects at enrollment into the study
Key exclusion criteria (16 listed)
- active diarrhea;
- a history of daily consumption of fermented milk and/or yogurt;
- intolerance to lactose;
- pregnant/breastfeeding women;
- an active, non controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
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 |
|---|---|---|
| Lactobacillus acidophilus CL1285 and Lactobacillus caseiAlso: BioK CL1285One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen. | Dietary supplement | 1 |
| placeboOne bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen. | Dietary supplement | 2 |
Primary outcome
The Incidence of Antibiotic-associated Diarrhea.
Time frame: Up to 40 days
Presence of at least one diarrhea episode within 24 hours.
3 secondary outcomes
Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.
Time frame: Up to 40 days
Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
Time frame: Up to 40 days
Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics
Time frame: Up to 40 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joe S Dylewski, MD principal investigator
St-Mary Hospital Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus acidophilus CL1285 and Lactobacillus casei in people with Diarrhea and Clostridium Infections, run by Bio-K Plus International Inc. at 8 sites 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Incidence of Antibiotic-associated Diarrhea. (time frame: Up to 40 days). 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 7 Aug 2014.