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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01048567
Recruitment Status : Terminated (Insufficient resources to meet enrollment target)
First Posted : January 13, 2010
Last Update Posted : December 19, 2013
Jamieson Laboratories Ltd, Canada
Canadian Society of Hospital Pharmacists
Information provided by (Responsible Party):
Curtis Harder, 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.

Condition or disease Intervention/treatment Phase
Diarrhea Clostridium Difficile Other: Lactobacillus acidophilus/rhamnosus Other: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Lactobacillus Acidophilus/Rhamnosus Complex for the Prevention of Antibiotic-associated Diarrhea in Elderly Hospitalized Patients
Study Start Date : September 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
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 Name: Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)

Placebo Comparator: Placebo Other: Placebo
2 capsules three times daily for entire duration of antibiotic therapy.

Primary Outcome Measures :
  1. Incidence of AAD defined as 3 or more loose stools in a 24 hour period. [ Time Frame: Monitored cnce daily at start of study product, then weekly x 3 weeks after last antibiotic dose ]

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

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01048567

Canada, British Columbia
General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8Z 6R5
Sponsors and Collaborators
Vancouver Island Health Authority
Jamieson Laboratories Ltd, Canada
Canadian Society of Hospital Pharmacists
Principal Investigator: Curtis Harder, BSc. Pharm, ACPR, Pharm D Vancouver Island Health Authority

Responsible Party: Curtis Harder, Clinical Pharmacy Specialist, Vancouver Island Health Authority Identifier: NCT01048567     History of Changes
Other Study ID Numbers: VIHA2009-82
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Curtis Harder, Vancouver Island Health Authority:
Clostridium difficile
Prevention & control

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents