Comparison of Two Formulations of Bio-K

Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study

Main research Question: The investigators would like to find out if both the Bio-K (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective in the prevention of diarrhea associated with antibiotic use.

Why is this research project important? About 25% of patients who use antibiotics may develop diarrhea as a side effect. Symptoms are mild and consist of watery diarrhea and abdominal pain. Some patients may develop a more severe form of diarrhea, called clostridium difficile-associated diarrhea. Clostridium difficile-associated diarrhea may lead to more serious consequences like inflammation of the large bowel and in some cases, death. There are some studies that suggest Bio-K drink, a probiotic preparation containing lactobacillus acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. As a result, St. Joseph's Healthcare has recently to use Bio-K routinely to try to reduce risk of patients developing diarrhea. No other Hamilton hospitals use Bio-K routinely as there is not strong evidence about the effectiveness of Bio-K for the prevention of diarrhea. This study will provide more information about Bio-K's effectiveness in the prevention of diarrhea associated with antibiotic use as both a capsule and a drink.

Study Overview

• Status: Unknown
• Conditions: Antibiotic-Associated Diarrhea
• Intervention / Treatment: Dietary supplement: Bio-K capsule formulation; Dietary supplement: Bio-K drink

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton - Charlton Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• speak English
• capable of providing consent
• reachable by telephone within the next three months
• willing to comply with study protocols
• age over 65 years
• prescribed clindamycin, fluoroquinolones or cephalosporin for more than one dose

Exclusion Criteria:

• ICU patients
• transplant patients
• patients on immunosuppressant medications (prednisone greater than 50 mg/day for 7 days, azathioprine, cyclosporine, cyclophosphamide, tacrolimus, sirolimus, methotrexate, mycophenolate, anti-TNF agents, interleukin-2 chemotherapy)
• HIV patients with CD4+ count less than 250 cells/mm3
• neutropenic patients with total neutrophil count less than 500
• patients with prosthetic heart valves

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bio-K capsule; 1 capsule of lactobacillus acidophilus and lactobacillus casei (50 billion live bacteria) daily for duration of antibiotic therapy and 7 days after or until discharge, whichever comes first	Dietary supplement: Bio-K capsule formulation; Bio-K 1 capsule formulation daily for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first
ACTIVE_COMPARATOR: Bio-K liquid; 98 g of lactobacillus acidophilus and lactobacillus casei (50 billion live bacteria) daily for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever comes first	Dietary supplement: Bio-K drink; Bio-K 98 g of diary-free soy beverage formulation for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first
NO_INTERVENTION: no Bio-K; No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antibiotic-associated diarrhea	30 days after termination of antibiotic

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ANTICIPATED): May 1, 2009
• Study Completion (ANTICIPATED): May 1, 2009

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 17, 2008
• First Posted (ESTIMATE): November 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2008
• Last Update Submitted That Met QC Criteria: November 17, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 1-Seto