DiarrheaPhase 3NCT00737412
Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults
A Phase 3 study testing Probiotic: Bio-K+ CL1285 in people with Diarrhea, run by Bio-K Plus International Inc. at 4 sites in Canada.
Trial summary
The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Probiotic: Bio-K+ CL1285
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 4 sitesCanada
- Study dates
- Apr 2008to Jan 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects over 18 years of age traveling to Mexico, Central America, South America and Caribbean Islands as direct destinations or on cruises to the same destinations.
- The trips last a minimum of 7 days and a maximum of 21 days.
- 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
- active diarrhea;
- pregnancy; breastfeeding
- 3 diarrheic episodes within 24 hours in the 15 days preceding the date of the departure;
- antibiotic treatment during the last 15 days or ongoing treatment at the time of departure;
- consumption of fermented milk, yogourt or probiotics probiotics in the 15 days preceding the date of the departure;
- immunosuppressed state or any health condition being susceptible to decompensate during the study (including malignant hemo-pathologies, AIDS, bone marrow transplant or organ transplant).
Show all 15Show fewer
- active radiotherapy or chemotherapy as cancer treatment
- the administration of an ETEC/cholera vaccine or any other diarrhea vaccine in the three months prior to study initiation
- an active, non-controlled intestinal disease;
- ileostomy, jejunostomy or colostomy
- concomitant participation in another clinical trial
- 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, and unlikelihood of completing the study,
- allergies to any ingredients in the study product (active product or placebo)
- current use of illicit drug and alcohol abuse
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Clinique Santé Voyage des Prairies
Joliette, Quebec, J6E 1G2
Clinique Santé Voyage de Laval
Laval, Quebec, H7G2E6
Clinique Santé Voyage Saint-Luc
Montreal, Quebec, H2X 2H9
Sant Voyage Medisys
Montreal, Quebec, H3A 3C6
About this study
Official title: A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults.
The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.
Read the detailed description
Determine efficacy of Bio-K+ CL1285 in reducing Traveler's Diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada following either Bio-K+ CL-1285 OR placebo prophylaxis.
- Conditions
- Diarrhea
- Being tested
- Probiotic: Bio-K+ CL1285, Placebo
- Keywords
- Bio-K+CL1285, Probiotics, Traveler's Diarrhea, Lactobacillus Acidophilus, Lactobacillus Casei
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic: Bio-K+ CL1285Other
Also called Bio-K+ CL1285 RX®
The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
PlaceboOther
Matching capsules devoid of microorganisms
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The probiotic Bio-K+ CL1285 RX® Receives: Other: Probiotic: Bio-K+ CL1285 |
| 2 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of Bio-K+ CL1285 RX® in reducing traveler's diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
Measured: March 2008 to April 2009
Secondary outcomes (4)
To compare the severity of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
Measured: March 2008 to April 2009
To compare the safety profile of BIO-K+CL1285 RX® to that of placebo
Measured: March 2008 to April 2009
To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo
Measured: March 08 to April 09
To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®.
Measured: March 08 to April 09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-K Plus International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Investigators
- Dominique Tessier, MD, Principal investigator, Sante Voyage MedisysBenoit Brizard, MD, Principal investigator, Clinique Santé Voyage de LavalBenoit Cote, MD, Principal investigator, Clinique Sante Voyage des PrairiesJean Vincelette, MD, Principal investigator, Sante Voyage Saint-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737412
- Sponsor's protocol ID
- CL1285-TD-M02
- Status last verified
- Jan 2010
- First submitted
- 15 Aug 2008
- Last updated
- 21 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2010. 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 of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults.
- ClinicalTrials.gov ID
- NCT00737412
- Acronym / sponsor ID
- CL1285-TD-M02
- Conditions
- Diarrhea
- Keywords
- Bio-K+CL1285, Probiotics, Traveler's Diarrhea, Lactobacillus Acidophilus, Lactobacillus Casei
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Bio-K Plus International Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc.
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Aug 2008 (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.
The purpose of this study is to determine the efficacy of Bio-K+ CL1285 in reducing traveler's diarrhea.
Detailed description
Determine efficacy of Bio-K+ CL1285 in reducing Traveler's Diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada following either Bio-K+ CL-1285 OR placebo prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Probiotic: Bio-K+ CL1285The probiotic Bio-K+ CL1285 RX® |
| 2 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects over 18 years of age traveling to Mexico, Central America, South America and Caribbean Islands as direct destinations or on cruises to the same destinations.
- The trips last a minimum of 7 days and a maximum of 21 days.
- 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.
Key exclusion criteria (15 listed)
- active diarrhea;
- pregnancy; breastfeeding
- 3 diarrheic episodes within 24 hours in the 15 days preceding the date of the departure;
- antibiotic treatment during the last 15 days or ongoing treatment at the time of departure;
- consumption of fermented milk, yogourt or probiotics probiotics in the 15 days preceding the date of the departure;
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 |
|---|---|---|
| Probiotic: Bio-K+ CL1285Also: Bio-K+ CL1285 RX®The probiotic Bio-K+ CL1285 RX®, a mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose. | Other | 1 |
| PlaceboMatching capsules devoid of microorganisms | Other | 2 |
Primary outcome
To determine the efficacy of Bio-K+ CL1285 RX® in reducing traveler's diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
Time frame: March 2008 to April 2009
4 secondary outcomes
To compare the severity of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis.
Time frame: March 2008 to April 2009
To compare the safety profile of BIO-K+CL1285 RX® to that of placebo
Time frame: March 2008 to April 2009
To compare the physician and traveler satisfaction following daily prophylaxis with either BIO-K+CL1285 RX® or placebo
Time frame: March 08 to April 09
To evaluate and compare the health economic impact of daily prophylaxis with BIO-K+CL1285 RX®.
Time frame: March 08 to April 09
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2010.
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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.
Dominique Tessier, MD principal investigator
Sante Voyage Medisys
Benoit Brizard, MD principal investigator
Clinique Santé Voyage de Laval
Benoit Cote, MD principal investigator
Clinique Sante Voyage des Prairies
4 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 Probiotic: Bio-K+ CL1285 in people with Diarrhea, run by Bio-K Plus International Inc. at 4 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 3 inclusion and 15 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 21 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 determine the efficacy of Bio-K+ CL1285 RX® in reducing traveler's diarrhea by comparing the incidence of diarrhea in travelers during their stay abroad and upon their return to Canada, following either BIO-K+CL1285 RX® or placebo prophylaxis. (time frame: March 2008 to April 2009). 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 21 Jan 2010.