Clinical trial NCT01048567: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diarrhea
Clostridium Difficile
Keywords: Antibiotics
Diarrhea
Clostridium difficile
Probiotics
Prevention & control
Lead sponsor: Vancouver Island Health Authority
Sponsor class: OTHER
Collaborators: name: Jamieson Laboratories Ltd, Canada
name: Canadian Society of Hospital Pharmacists
First posted: 2010-01-13
Enrollment: 7
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of AAD defined as 3 or more loose stools in a 24 hour period.
timeFrame: Monitored cnce daily at start of study product, then weekly x 3 weeks after last antibiotic dose
Secondary outcomes:
measure: Incidence of CDI as detected by a stool assay (detection of toxins A or B)
timeFrame: Measured if diarrhea develops in hospital during antibiotic treatment or during the 3 weeks following last antibiotic dose
measure: Duration of hospital stay
timeFrame: Day of hospital admission until day of discharge
measure: Incidence of adverse effects
timeFrame: Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority
state: British Columbia
Study officials:
affiliation: Vancouver Island Health Authority
name: Curtis Harder, BSc. Pharm, ACPR, Pharm D
role: PRINCIPAL_INVESTIGATOR
References: