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

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.

Study Overview

• Status: Terminated
• Conditions: Diarrhea; Clostridium Difficile
• Intervention / Treatment: Other: Lactobacillus acidophilus/rhamnosus; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8Z 6R5
      • General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 2 capsules three times daily for entire duration of antibiotic therapy.
Active Comparator: Lactobacillus acidophilus/rhamnosus	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vancouver Island Health Authority
• Collaborators: Canadian Society of Hospital Pharmacists; Jamieson Laboratories Ltd, Canada
• Investigators: Principal Investigator: Curtis Harder, BSc. Pharm, ACPR, Pharm D, Vancouver Island Health Authority

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Diarrhea; Probiotics; Antibiotics; Clostridium difficile; Prevention & control
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: VIHA2009-82