Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 629
- 试验地点
- 11
- 主要终点
- Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary
研究概览
简要总结
Primary Objective:
To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children.
Secondary Objectives:
To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes.
To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).
详细描述
The maximum duration of study participation for each patient can be 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Enterogermina + Enterolyte
2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation
干预措施: Bacillus clausii (Drug)
Enterogermina + Enterolyte
2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation
干预措施: Oral Rehydration Therapy (Drug)
结局指标
主要结局
Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary
时间窗: from Day 1 to Day 5
次要结局
- Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina(Day 1 to Day 5)
- Parent / Legal guardian's assessment of children's overall general state(Day 1 to Day 5)
- Effect on consistency of stool(Day 1 to Day 5)
- Mean number of stools per day(Day 1 to Day 5)
- Number of vomiting episodes per day(Day 1 to Day 5)
- Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator(Day 1 to Day 5)