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

NCT01048567 | Terminated Phase 2

• 1 other identifier: VIHA2009-82
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Clostridium Difficile

Keywords

Antibiotics; Diarrhea; Clostridium difficile; Probiotics; Prevention & control

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Duration of hospital stay

  Day of hospital admission until day of discharge

• Incidence of adverse effects

  Monitored daily at start of study product, then weekly x 3 weeks after last antibiotic dose

Study Arms (2)

Lactobacillus acidophilus/rhamnosus

ACTIVE COMPARATOR

Other: Lactobacillus acidophilus/rhamnosus

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Lactobacillus acidophilus/rhamnosus OTHER

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

Also known as: Lactobacillus Acidophilus Probiotic Complex (by Jamieson Laboratories Ltd, Canada)

Lactobacillus acidophilus/rhamnosus

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver Island Health Authority: lead
• Jamieson Laboratories Ltd, Canada: collaborator
• Canadian Society of Hospital Pharmacists: collaborator

Study Sites (1)

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

Victoria, British Columbia, V8Z 6R5, Canada

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Curtis Harder, BSc. Pharm, ACPR, Pharm D

  Vancouver Island Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

CA (1)