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临床试验/NCT00792844
NCT00792844Unknown不适用

Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study

McMaster University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
1
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

研究组 & 干预措施

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

干预措施: Bio-K drink (Dietary Supplement)

no Bio-K

No Intervention

No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)

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

干预措施: Bio-K capsule formulation (Dietary Supplement)

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

研究者

申办方类型
Other

研究点 (1)

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