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

Phase 2

Terminated

• Conditions: Diarrhea; Clostridium Difficile
• Interventions: Other: Lactobacillus acidophilus/rhamnosus; Other: Placebo

• Registration Number: NCT01048567
• Lead Sponsor: Vancouver Island Health Authority

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.

Study Timeline

• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Study Start: 2011-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus acidophilus/rhamnosus	Lactobacillus acidophilus/rhamnosus	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of AAD defined as 3 or more loose stools in a 24 hour period.	Monitored cnce daily at start of study product, then weekly x 3 weeks after last antibiotic dose

Secondary Outcome Measures

Name	Time	Method
Incidence of CDI as detected by a stool assay (detection of toxins A or B)	Measured if diarrhea develops in hospital during antibiotic treatment or during the 3 weeks following last antibiotic dose
Duration of hospital stay	Day of hospital admission until day of discharge
Incidence of adverse effects	Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose

Trial Locations

Locations (1)

General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority; 🇨🇦 Victoria, British Columbia, Canada