Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Changes of gut microbiota during antibiotic treatment
研究概览
简要总结
Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.
详细描述
Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment.
The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An infection requiring antibiotic treatment assessed by a doctor
排除标准
- •Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study
结局指标
主要结局
Changes of gut microbiota during antibiotic treatment
时间窗: One week
Gut microbiota and antibiotics - Prevention of side effects by new prebiotics
次要结局
未报告次要终点