The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- IgE sensitization
研究概览
简要总结
Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.
详细描述
Newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. The proof of concept trial will be double blind. Intervention will start at the age of 2 months and it will end when children become 12 months old. Children will be randomized to the two arms. IgE sensitization is the primary outcome at the age of two and three years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind randomized trial
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both parents have atopy
排除标准
- •severe disease, particularly immune system deficiency or down syndrome or cancer
- •medication affecting immune system
- •birth before week 35 in pregnancy
- •being a twin
- •only one of the parents have atopy
- •none of the parents have atopy
- •children have passed the age of two months
- •immune system disorder such as rheumatoid disease, colitis ulcerosa, Crohn disease, diabetes or genetic risk to type 1 diabetes
- •no participation in national vaccination programme
研究组 & 干预措施
Placebo
The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.
干预措施: Nature-based materials (Combination Product)
intervention arm
The children will receive and they are exposed daily to materials of high microbiological biodiversity.
干预措施: Nature-based materials (Combination Product)
结局指标
主要结局
IgE sensitization
时间窗: 2-3 years
IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.
次要结局
- Allergic symptoms(2-3 years)
研究者
Aki Sinkkonen
University Researcher
University of Helsinki