Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
研究概览
简要总结
The purpose of this study is to know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea.
详细描述
The Antibiotic-Associated Diarrhea (AAD)is defined as that developed after the started antibiotic therapy ou until six to eight weeks after the end of the treatment. The occurence of AAD is about 5% to 25% of the patients using antibiotics and cause watery diarrhea, fever and vomit, mainly on pseudomembranous colitis. Several studies had demonstrated the use of probiotics as therapeutic or preventive form of AAD with or without the presence of C. difficile. About the tolerance of the probiotics,there weren´t observed deleterious effects on health with the consumption of 106 - 107 UFC of Lactobacillus spp and Bifidobacterium spp during a period of one year. The realization of this study can demonstrate the efficacy of Lactobacillus casei e Bifidobacterium breve at the treatment of AAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.
排除标准
- •Patients with chronic diarrhea, viral diarrhea, critical patients, during or after radio or chemiotherapy treatment,
- •HIV infections,
- •Ulcerative colitis,
- •Crohn´s disease,
- •Hydroelectrolytic disturbance,
- •Small intestine syndrome,
- •Colostomized, jejunostomized
- •Lactose intolerance,
- •Rapid enteral diet infusion (>120mh/h),
- •Hyperosmolar enteral diet.
结局指标
主要结局
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
时间窗: After 24 hours of the intervention started
次要结局
未报告次要终点