The Impact of Perinatal Daily Supplement of a Probiotic (Lactobacillus Rhamnosus GG), Given to Mothers, on Immunological Development, Atopic Sensitisation and Allergic Disease in Their Off-spring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 2
- 主要终点
- Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
研究概览
简要总结
A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo.
详细描述
To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establishment and composition of the gut microflora in children from birth until two years of age.
At the same time to investigate the relationship between gut flora composition and the development of the immune system.
To investigate the relationship between supplement of probiotics to pregnant and breast-feeding women, the microbial composition of the gut flora in their children, the development of the childrens' immune system, and the prevalence of atopic sensitisation and atopic disease at two years of age.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All pregnant women understanding Norwegian language and who has signed an informed consent form, can be included.
- •Inclusion must take place before week 36 in the pregnancy.
- •The woman must plan to breast-feed the first 4 months after birth.
- •She must live in Trondheim.
排除标准
- •Not being able to fill in the questionnaire in Norwegian language
- •Lactose intolerance
- •Consumption of probiotics earlier in the pregnancy.
- •Intention to move from Trondheim in the next 25 months.
- •Pregnant women in risk of eclampsia, or other serious disease that can influence beast-feeding or care for the child.
结局指标
主要结局
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
时间窗: 2 years
次要结局
- Intestinal colonisation with LGG.(2 years)
- Atopic sensitization(2 years)
- Positive skin prick test (SPT), elevated total IgE and elevated specific IgE(2 years)
- TGF in breastmilk(2 years)
- Cytokine profile from activated PBMC(2 years)
- Intestinal microflora(2 years)
- Oral cavity colonisation with LGG.(2 years)
- Immunomarkers(2 years)