Trial | NCT01048567  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    7
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 Started
Sep 30
2011
Primary Completion
Oct 31
2011
Study Completion
Oct 31
2011
Last Update
Dec 19
2013
Estimate

Other Lactobacillus acidophilus/rhamnosus

2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy

  • Other names: Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)

Other Placebo

2 capsules three times daily for entire duration of antibiotic therapy.

Lactobacillus acidophilus/rhamnosus Active Comparator

Placebo Placebo Comparator

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.
No Results Posted