EUCTR2014-004636-19-Outside-EU/EEA进行中（未招募）不适用
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 - ENIGMA ( Enterogermina™ n the ManaGeMent of DiarrheA in Children)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 264
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
研究者
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