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

NCT ID: NCT01048567

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-10-31

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.

Conditions

Diarrhea; Clostridium Difficile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Lactobacillus acidophilus/rhamnosus

Group Type: ACTIVE_COMPARATOR

Lactobacillus acidophilus/rhamnosus

Intervention Type: OTHER

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Lactobacillus acidophilus/rhamnosus

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jamieson Laboratories Ltd, Canada

UNKNOWN

Sponsor Role: collaborator

Canadian Society of Hospital Pharmacists

OTHER

Sponsor Role: collaborator

Vancouver Island Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Curtis Harder

Clinical Pharmacy Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Curtis Harder, BSc. Pharm, ACPR, Pharm D

Role: PRINCIPAL_INVESTIGATOR

Vancouver Island Health Authority

Locations

General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority

Victoria, British Columbia, Canada

Countries

Canada

Other Identifiers

VIHA2009-82

Identifier Type: -

Identifier Source: org_study_id