NCT00748748已完成1 期
Effect of Lactobacillus Probiotic on Healthy Adults
Fargo VA Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of diarrhea
研究概览
简要总结
Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the risk of other infections, develop into more serious forms of disease, and lead to premature discontinuation of the needed antibiotic. The purpose of this study is to examine the safety and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of diarrhea associated with antibiotic use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants (male or female inpatients) 18 to 64 years of age who are prescribed antibiotics (single or multiple antibiotics, oral or intravenous) will be recruited from the Fargo VAMC Primary Care Clinic area.
- •Participants must be able to swallow a capsule.
排除标准
- •Exclusion criteria include diarrhea on admission or within the preceding week
- •Reported recurrent diarrhea
- •Antibiotics in the past four weeks
- •Significant underlying conditions (e.g. diabetes, structural cardiac defects including valvular defects, history of infective endocarditis, poor cardiac function, immunosuppression, impaired gut integrity, moderate or serious intestinal disorders, malignancies, pancreatitis, indwelling catheters, recent surgery, recent prolonged hospitalization)
- •Previous bowel surgery
- •Nutritional restrictions that preclude participation
- •Hypersensitivity to penicillin G, ampicillin, or erythromycin
- •Persons who have been prescribed their antibiotic for a duration longer than 3 weeks
结局指标
主要结局
Incidence of diarrhea
时间窗: Approximately one month
次要结局
未报告次要终点
研究者
Stephanie Borchardt
Tze Shien Lo, MD
Fargo VA Medical Center
研究点 (2)
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