NCT00265369已完成3 期
Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children
适应症
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
- 420
- 试验地点
- 2
- 主要终点
- Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools
研究概览
简要总结
Primary objective:
- To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
Secondary objective:
- To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
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
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants or Children
- •Non hospitalized infants or children
- •With acute diarrhea evident for less than 48 hours
- •Having had three or more watery stools during the preceding 24 hours
排除标准
- •Infants or Children
- •With blood stools
- •Having been treated with antibiotics or probiotics within the two weeks before the enrollment
- •Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold
- •With an history of seizures
- •With immunosuppressive conditions
- •With a current status requiring an antibiotic treatment
- •Suffering from a chronic disease including chronic diarrhea whatever the origin
- •Having received before inclusion one of the following treatments:
- •Probiotics
- •Prebiotics
- •Drugs with adsorbing properties
- •Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan
- •Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents).
- •Having participated in another clinical trial in the last 3 months prior to the start of the study
结局指标
主要结局
Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools
次要结局
- Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria
研究者
研究点 (2)
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