DiarrheaPhase 2NCT01048567
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
A Phase 2 study testing Lactobacillus acidophilus/rhamnosus in people with Diarrhea and Clostridium Difficile, run by Vancouver Island Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether Lactobacillus acidophilus/rhamnosus complex is effective in the prevention of antibiotic-associated diarrhea (AAD) in the elderly. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diarrhea, Clostridium Difficile
- What is being tested?
- Lactobacillus acidophilus/rhamnosus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Oct 2011
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients over the age of 60 on 4A/B unit at Victoria General Hospital, Victoria BC, and
- Anticipated to receive antibiotics (intravenous or oral) for greater than 72 hours for any indication, and
- Are determined to be competent by the prescriber.
Who cannot join
- Patients who have been on antibiotics during the past 2 weeks
- Patients who have active diarrhea at enrollment
- Patients who have been diagnosed with CDI within the previous 3 months
- Patients who are lactose intolerant
- Patients who have an underlying chronic GI tract disease (inflammatory bowel disease, irritable bowel syndrome)
- Patients who have an ileostomy or colostomy
Show all 13Show fewer
- Patients who regularly take probiotics
- Patients who are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year)
- Patients who have a life-threatening illness
- Patients who cannot take medications by mouth or are tube fed
- Patients who have been on the new antibiotic for more than 72 hours
- Patients who are anticipated to receive the new antibiotic for a duration of less than 72 hours
- Patients who do no give informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority
Victoria, British Columbia, V8Z 6R5
About this study
Official title: Use of Lactobacillus Acidophilus/Rhamnosus Complex for the Prevention of Antibiotic-associated Diarrhea in Elderly Hospitalized Patients
The purpose of this study is to determine whether Lactobacillus acidophilus/rhamnosus complex is effective in the prevention of antibiotic-associated diarrhea (AAD) in the elderly.
Read the detailed description
Antibiotic-associated diarrhea (AAD) is a common adverse drug reaction, occurring in 5-35% of patients, and is of significant consequence to hospitalized patients. Patients who develop AAD are more likely to experience a longer hospital stay, incur higher medical costs, and develop other co-morbidities. Clostridium difficile infection (CDI) accounts for approximately 15-25% of AAD cases and is a significant cause of morbidity and mortality in hospitalized geriatric patients.
A preventative measure that has been suggested for AAD and CDI is the use of probiotics. Although probiotics have been used for a wide range of indications, including the prevention and treatment of AAD and CDI, there is lack of data regarding efficacy of these products.
Hospitalized elderly patients are at significant risk of developing AAD and CDI and prevention of AAD and CDI in this population may contribute to a reduction in morbidity, length of hospital stay, medical costs, and potentially mortality.
- Conditions
- Diarrhea, Clostridium Difficile
- Being tested
- Lactobacillus acidophilus/rhamnosus, Placebo
- Keywords
- Antibiotics, Diarrhea, Clostridium difficile, Probiotics, Prevention & control
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilus/rhamnosusOther
Also called Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)
2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy
PlaceboOther
2 capsules three times daily for entire duration of antibiotic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus acidophilus/rhamnosus | Active comparator | Not described Receives: Other: Lactobacillus acidophilus/rhamnosus |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AAD defined as 3 or more loose stools in a 24 hour period.
Measured: Monitored cnce daily at start of study product, then weekly x 3 weeks after last antibiotic dose
Secondary outcomes (3)
Incidence of CDI as detected by a stool assay (detection of toxins A or B)
Measured: Measured if diarrhea develops in hospital during antibiotic treatment or during the 3 weeks following last antibiotic dose
Duration of hospital stay
Measured: Day of hospital admission until day of discharge
Incidence of adverse effects
Measured: Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Insufficient resources to meet enrollment target
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver Island Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Jamieson Laboratories Ltd, Canada, Canadian Society of Hospital Pharmacists
- Responsible party
- Principal investigator, Curtis Harder, Vancouver Island Health Authority
- Investigators
- Curtis Harder, BSc. Pharm, ACPR, Pharm D, Principal investigator, Vancouver Island Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048567
- Sponsor's protocol ID
- VIHA2009-82
- Status last verified
- Dec 2013
- First submitted
- 12 Jan 2010
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lactobacillus Acidophilus/Rhamnosus Complex for the Prevention of Antibiotic-associated Diarrhea in Elderly Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01048567
- Acronym / sponsor ID
- VIHA2009-82
- Conditions
- Diarrhea, Clostridium Difficile
- Keywords
- Antibiotics, Diarrhea, Clostridium difficile, Probiotics, Prevention & control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient resources to meet enrollment target
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Collaborators
- Jamieson Laboratories Ltd, Canada, Canadian Society of Hospital Pharmacists
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Jan 2010 (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 whether Lactobacillus acidophilus/rhamnosus complex is effective in the prevention of antibiotic-associated diarrhea (AAD) in the elderly.
Detailed description
Antibiotic-associated diarrhea (AAD) is a common adverse drug reaction, occurring in 5-35% of patients, and is of significant consequence to hospitalized patients. Patients who develop AAD are more likely to experience a longer hospital stay, incur higher medical costs, and develop other co-morbidities. Clostridium difficile infection (CDI) accounts for approximately 15-25% of AAD cases and is a significant cause of morbidity and mortality in hospitalized geriatric patients.
A preventative measure that has been suggested for AAD and CDI is the use of probiotics. Although probiotics have been used for a wide range of indications, including the prevention and treatment of AAD and CDI, there is lack of data regarding efficacy of these products.
Hospitalized elderly patients are at significant risk of developing AAD and CDI and prevention of AAD and CDI in this population may contribute to a reduction in morbidity, length of hospital stay, medical costs, and potentially mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus acidophilus/rhamnosus | Active comparator | Other: Lactobacillus acidophilus/rhamnosus |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatients over the age of 60 on 4A/B unit at Victoria General Hospital, Victoria BC, and
- Anticipated to receive antibiotics (intravenous or oral) for greater than 72 hours for any indication, and
- Are determined to be competent by the prescriber.
Key exclusion criteria (13 listed)
- Patients who have been on antibiotics during the past 2 weeks
- Patients who have active diarrhea at enrollment
- Patients who have been diagnosed with CDI within the previous 3 months
- Patients who are lactose intolerant
- Patients who have an underlying chronic GI tract disease (inflammatory bowel disease, irritable bowel syndrome)
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/rhamnosusAlso: Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy | Other | Lactobacillus acidophilus/rhamnosus |
| Placebo2 capsules three times daily for entire duration of antibiotic therapy. | Other | Placebo |
Primary outcome
Incidence of AAD defined as 3 or more loose stools in a 24 hour period.
Time frame: Monitored cnce daily at start of study product, then weekly x 3 weeks after last antibiotic dose
3 secondary outcomes
Incidence of CDI as detected by a stool assay (detection of toxins A or B)
Time frame: Measured if diarrhea develops in hospital during antibiotic treatment or during the 3 weeks following last antibiotic dose
Duration of hospital stay
Time frame: Day of hospital admission until day of discharge
Incidence of adverse effects
Time frame: Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose
Results and safety
The study was stopped early (reason given: Insufficient resources to meet enrollment target). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Curtis Harder, BSc. Pharm, ACPR, Pharm D principal investigator
Vancouver Island Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus acidophilus/rhamnosus in people with Diarrhea and Clostridium Difficile, run by Vancouver Island Health Authority 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 3 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 19 Dec 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Insufficient resources to meet enrollment target). 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?
Incidence of AAD defined as 3 or more loose stools in a 24 hour period. (time frame: Monitored cnce daily at start of study product, then weekly x 3 weeks after last antibiotic dose). 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 19 Dec 2013.