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

Diarrhea Clinical Trial

Official title:

Use of Lactobacillus Acidophilus/Rhamnosus Complex for the Prevention of Antibiotic-associated Diarrhea in Elderly Hospitalized Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01048567
• Other study ID #: VIHA2009-82
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2010
• Last updated: December 17, 2013
• Start date: September 2011
• Est. completion date: October 2011

Study information

• Verified date: December 2013
• Source: Vancouver Island Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Clostridium Difficile
• Diarrhea

Intervention

Other:
• Lactobacillus acidophilus/rhamnosus
2 capsules (at least 2 billion cells per capsule) three times daily for duration of antibiotic therapy
• Placebo
2 capsules three times daily for entire duration of antibiotic therapy.

Locations

Country	Name	City	State
Canada	General Medicine Unit 4 A/B at Victoria General Hospital, Vancouver Island Health Authority	Victoria	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Vancouver Island Health Authority	Canadian Society of Hospital Pharmacists, Jamieson Laboratories Ltd, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Duration of hospital stay		Day of hospital admission until day of discharge	No
Secondary	Incidence of adverse effects		Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose	Yes