Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- weight gain
研究概览
简要总结
Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted
详细描述
In this study, children with abnormal weight development of BMI will be recruited and the gut microbiota will be modified using one of there treatment schedules. The subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic Lactobacillus rhamnosus GG or 2) placebo drink and/or 3) drink with Lactobacillus rhamnosus GG.
The children will give a faecal sample in the beginning and at the end and similarly also a blood sample. The faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. Blood samples will be analysed for obesity related biomarkers.
Body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development
排除标准
- •Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics
结局指标
主要结局
weight gain
时间窗: 3 months
body weight
次要结局
- Weight change(3 months)
- Blood biomarkers(3 months)
研究者
Erika Isolauri
Professori
Turku University Hospital