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Comparison of Two Formulations of Bio-K

Primary Purpose

Antibiotic-Associated Diarrhea

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bio-K capsule formulation
Bio-K drink
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic-Associated Diarrhea

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton - Charlton Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Bio-K capsule

Bio-K liquid

no Bio-K

Arm Description

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

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

No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)

Outcomes

Primary Outcome Measures

Antibiotic-associated diarrhea

Secondary Outcome Measures

Full Information

First Posted
November 17, 2008
Last Updated
November 17, 2008
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT00792844
Brief Title
Comparison of Two Formulations of Bio-K
Official Title
Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
McMaster University

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-Associated Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bio-K capsule
Arm Type
Experimental
Arm Description
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
Arm Title
Bio-K liquid
Arm Type
Active Comparator
Arm Description
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
Arm Title
no Bio-K
Arm Type
No Intervention
Arm Description
No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)
Intervention Type
Dietary Supplement
Intervention Name(s)
Bio-K capsule formulation
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Bio-K drink
Intervention Description
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
Primary Outcome Measure Information:
Title
Antibiotic-associated diarrhea
Time Frame
30 days after termination of antibiotic

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gloria Seto, BSchPhm
Phone
905-522-1155
Ext
33803
Email
gseto@stjosham.on.ca
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton - Charlton Campus
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Seto
Email
gseto@stjosham.on.ca
First Name & Middle Initial & Last Name & Degree
Gloria Seto, BScPhm

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Formulations of Bio-K

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