Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Antibiotic-associated diarrhea
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Antibiotic-associated diarrhea
时间窗: 30 days after termination of antibiotic
次要结局
未报告次要终点
