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Comparison of Two Formulations of Bio-K

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by McMaster University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792844
First Posted: November 18, 2008
Last Update Posted: November 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McMaster University
November 17, 2008
November 18, 2008
November 18, 2008
February 2009
May 2009   (Final data collection date for primary outcome measure)
Antibiotic-associated diarrhea [ Time Frame: 30 days after termination of antibiotic ]
Same as current
No Changes Posted
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Antibiotic-Associated Diarrhea
  • 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
  • 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
  • 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
    Intervention: Dietary Supplement: Bio-K capsule formulation
  • 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
    Intervention: Dietary Supplement: Bio-K drink
  • No Intervention: no Bio-K
    No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
90
May 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00792844
1-Seto
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Gloria Seto, St. Joseph's Healthcare Hamilton
McMaster University
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McMaster University
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP