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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Diarrhea Clostridium Difficile

Keywords

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Antibiotics Diarrhea Clostridium difficile Probiotics Prevention & control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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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

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

Eligibility Criteria

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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

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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

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Curtis Harder

Clinical Pharmacy Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Curtis Harder, BSc. Pharm, ACPR, Pharm D

Role: PRINCIPAL_INVESTIGATOR

Vancouver Island Health Authority

Locations

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

Victoria, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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VIHA2009-82

Identifier Type: -

Identifier Source: org_study_id