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

This study has been terminated.
(Insufficient resources to meet enrollment target)
Sponsor:
Collaborators:
Jamieson Laboratories Ltd, Canada
Canadian Society of Hospital Pharmacists
Information provided by (Responsible Party):
Curtis Harder, Vancouver Island Health Authority
ClinicalTrials.gov Identifier:
NCT01048567
First received: January 12, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Diarrhea
Clostridium Difficile
Other: Lactobacillus acidophilus/rhamnosus
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Vancouver Island Health Authority:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: Day of hospital admission until day of discharge ] [ Designated as safety issue: No ]
  • Incidence of adverse effects [ Time Frame: Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048567

Locations
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
Investigators
Principal Investigator: Curtis Harder, BSc. Pharm, ACPR, Pharm D Vancouver Island Health Authority
  More Information

No publications provided

Responsible Party: Curtis Harder, Clinical Pharmacy Specialist, Vancouver Island Health Authority
ClinicalTrials.gov Identifier: NCT01048567     History of Changes
Other Study ID Numbers: VIHA2009-82
Study First Received: January 12, 2010
Last Updated: December 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by Vancouver Island Health Authority:
Antibiotics
Diarrhea
Clostridium difficile
Probiotics
Prevention & control

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 17, 2014