NCT00457353已完成3 期
Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Reduction in duration of diarrhea
研究概览
简要总结
Primary:
- To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children
Secondary:
- To evaluate the safety of Enterogermina® in acute diarrhea in Indian children
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
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration
排除标准
- •History of presence of blood, pus, or mucus in stools
- •Severe dehydration (World Health Organization criteria)
- •Severely malnourished patients
- •Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
- •History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
- •Known hypersensitivity to Bacillus clausii or other probiotics.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Active Comparator
Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii)
干预措施: Bacillus Clausii (Drug)
2
Placebo Comparator
Administration of Oral rehydration therapy
干预措施: Oral rehydration therapy (Other)
结局指标
主要结局
Reduction in duration of diarrhea
时间窗: Throughout the treatment period
Incidence of adverse events
时间窗: Throughout the study period
次要结局
- Mean number of stools per day(Throughout the treatment period)
- Effect on consistency of stools(Throughtout the treatment period)
- Vomiting episodes per day(Throughout the treatment period)
- Requirement of unscheduled intravenous transfusion(Throughout the study period)
- Need for hospitalization(Throughout the treatment period)
研究者
研究点 (1)
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