Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Development of Clostridium difficile associated diarrhea in patients receiving antibiotics
研究概览
简要总结
We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea
in a population of general inpatients who are receiving antibiotics.
详细描述
General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any hospitalized patient who is age 19 or older and receiving antibiotics.
排除标准
- •Feeding tube in place
- •Pregnancy
- •Milk or soy allergy
- •Sensitivity to lactose
- •Immunocompromised defined as:
- •Absolute neutrophil count (ANC) ≤ 500 cells/mm3
- •Cancer patient receiving chemotherapy or radiation therapy
- •Immune deficiency
- •Post organ transplant
- •Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.
结局指标
主要结局
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics
时间窗: Up to six months
次要结局
未报告次要终点