Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2009-02-28
2009-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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
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
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 Bio-K
No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)
No interventions assigned to this group
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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McMaster University
OTHER
Responsible Party
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St. Joseph's Healthcare Hamilton
Locations
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St. Joseph's Healthcare Hamilton - Charlton Campus
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Gloria Seto
Role: primary
Other Identifiers
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1-Seto
Identifier Type: -
Identifier Source: org_study_id