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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-K capsule | Experimental | 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 liquid | Active Comparator | 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 Bio-K | No Intervention | No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-K capsule formulation | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic-associated diarrhea | 30 days after termination of antibiotic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gloria Seto, BSchPhm | Contact | 905-522-1155 | 33803 | gseto@stjosham.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton - Charlton Campus | Hamilton | Ontario | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| Bio-K drink | Dietary Supplement | 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 |
|