Comparison of Two Formulations of Bio-K
- Conditions
- Antibiotic-Associated Diarrhea
- Registration Number
- NCT00792844
- Lead Sponsor
- McMaster University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Antibiotic-associated diarrhea 30 days after termination of antibiotic
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Joseph's Healthcare Hamilton - Charlton Campus
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton - Charlton Campus🇨🇦Hamilton, Ontario, CanadaGloria SetoContactgseto@stjosham.on.caGloria Seto, BScPhmPrincipal Investigator