Back to resultsEfficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
Primary Purpose
Diarrhea, Clostridium Difficile
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lactobacillus acidophilus/rhamnosus
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea focused on measuring Antibiotics, Diarrhea, Clostridium difficile, Probiotics, Prevention & control
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lactobacillus acidophilus/rhamnosus
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of AAD defined as 3 or more loose stools in a 24 hour period.
Secondary Outcome Measures
Incidence of CDI as detected by a stool assay (detection of toxins A or B)
Duration of hospital stay
Incidence of adverse effects
Full Information
NCT ID
NCT01048567
First Posted
January 12, 2010
Last Updated
December 17, 2013
Sponsor
Vancouver Island Health Authority
Collaborators
Jamieson Laboratories Ltd, Canada, Canadian Society of Hospital Pharmacists
1. Study Identification
Unique Protocol Identification Number
NCT01048567
Brief Title
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
Official Title
Use of Lactobacillus Acidophilus/Rhamnosus Complex for the Prevention of Antibiotic-associated Diarrhea in Elderly Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient resources to meet enrollment target
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vancouver Island Health Authority
Collaborators
Jamieson Laboratories Ltd, Canada, Canadian Society of Hospital Pharmacists
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Clostridium Difficile
Keywords
Antibiotics, Diarrhea, Clostridium difficile, Probiotics, Prevention & control
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus acidophilus/rhamnosus
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Lactobacillus acidophilus/rhamnosus
Other Intervention Name(s)
Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)
Intervention Description
2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2 capsules three times daily for entire duration of antibiotic therapy.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Duration of hospital stay
Time Frame
Day of hospital admission until day of discharge
Title
Incidence of adverse effects
Time Frame
Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Harder, BSc. Pharm, ACPR, Pharm D
Organizational Affiliation
Vancouver Island Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8Z 6R5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
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