NCT01048567

Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly

Use of Lactobacillus Acidophilus/Rhamnosus Complex for the Prevention of Antibiotic-associated Diarrhea in Elderly Hospitalized Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Vancouver Island Health Authority · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhea
• Clostridium Difficile

Interventions

Type	Name	Description
OTHER	Lactobacillus acidophilus/rhamnosus	2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy
OTHER	Placebo	2 capsules three times daily for entire duration of antibiotic therapy.

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-01-13
• Last updated: 2013-12-19

Locations

1 site across 1 country: Canada