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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
7
2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy
2 capsules three times daily for entire duration of antibiotic therapy.
General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority
Victoria, British Columbia, Canada
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
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