Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Duration of diarrhoea in hours
研究概览
简要总结
The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.
详细描述
Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute viral gastroenteritis
排除标准
- •Moderate or severe dehydration
- •Malnutrition
- •Immunodeficiencies
- •Sepsis or bacterial infection
- •Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
- •Hospitalisation
- •No phone number
- •Illiteracy
研究组 & 干预措施
Probiotics combination
LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu
干预措施: Probiotics combination (Dietary Supplement)
Placebo
Placebo sachet. One sachet orally, BID, for 5 days.
干预措施: Placebo (Other)
Saccharomyces boulardii
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
干预措施: Saccharomyces boulardii (Dietary Supplement)
结局指标
主要结局
Duration of diarrhoea in hours
时间窗: Up to 7 days
次要结局
- Percentage of children requiring hospitalisation(Up to 7 days)
- Adverse effects(Up to 7 days)
- Number of liquid stools(Up to seven days)
研究者
Giordano Perez Gaxiola
Pediatrician
Sinaloa Pediatric Hospital