Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
|Diarrhea Clostridium Difficile||Other: Lactobacillus acidophilus/rhamnosus Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Use of Lactobacillus Acidophilus/Rhamnosus Complex for the Prevention of Antibiotic-associated Diarrhea in Elderly Hospitalized Patients|
- 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 ]
- 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 ]
|Study Start Date:||September 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Lactobacillus acidophilus/rhamnosus||
Other: Lactobacillus acidophilus/rhamnosus
2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy
Other Name: Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)
|Placebo Comparator: Placebo||
2 capsules three times daily for entire duration of antibiotic therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048567
|Canada, British Columbia|
|General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority|
|Victoria, British Columbia, Canada, V8Z 6R5|
|Principal Investigator:||Curtis Harder, BSc. Pharm, ACPR, Pharm D||Vancouver Island Health Authority|