Comparison of Clinical Efficacy of Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Gastroenteritis symptoms duration.
研究概览
简要总结
This study evaluates a new drug, new enteroadsorbent polymethylsiloxane (Enterosgel) in the treatment of rotavirus gastroenteritis in children. Half of the participants received a new drug, polymethylsiloxane and half of the participants received standard treatment - probiotic L. reuteri (BioGaia).
详细描述
Polymethylsiloxane and probiotic L. reuteri both hasten symptoms of the rotavirus gastroenteritis but they do so by a different mode of action.
Polymethylsiloxane is an enteroadsorbent and it possibly acts by adsorption of viruses and doing so it prevents binding rotaviruses for enterocytes. Another mode of action can be forming a thin layer over the mucosal surfaces thus protects them from various damaging factors.
Probiotics help the healing of the intestinal mucosa presumably in few ways - by normalization of gut flora, by competition with pathogen bacteria for binding sites and nutrients and by stimulation of intestinal immune system.
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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 6-36 months
- •proven rotavirus gastroenteritis
- •symptom duration less than 48 hours
- •informed consent of the parents/caregivers
排除标准
- •rotavirus vaccination
- •rotavirus infection in a patient's history
- •severe acute or chronic illness with possible influence on rotavirus gastroenteritis outcome
研究组 & 干预措施
Polymethylsiloxane
Polymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days.
干预措施: Polymethylsiloxane (Dietary Supplement)
Lactobacillus reuteri
Probiotic Lactobacillus reuteri (BioGaia) is given 3 x 20 drops (which means 3 x 400,000.000 CFU) per day for five days.
干预措施: Lactobacillus reuteri (Dietary Supplement)
结局指标
主要结局
Gastroenteritis symptoms duration.
时间窗: 1-8 days.
Duration of the loose stools, fever and vomiting.
次要结局
- Total number of loose stools.(8 days)
- Duration of the hospitalization of any kind.(30 days)