ImmunoGarden - Effect of Modified Playground Environment on Health, Particularly Immune System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Interleukin 10 level in blood
研究概览
简要总结
Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed.
详细描述
Children of age 3-5 were randomly divided into two groups (arms). One received guidance and biodiverse material for 20 minutes each day for two weeks. The other received the a similar material and guidance but the microbial community in the material was poor in diversity. Bacterial community changes and immune system markers were analyzed and compared between the two arms. Potential changes in Interleukin 10 was the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants nor their parents did not know the arm. Care providers did not know the group as they did not know the content of the sand box. Investigators and field assistants knew the content in each sand box but they did not know the coding of the arms when they analyzed the differences in cytokine levels. Outcomes assessors i.e. nurses who took blood samples did not know the arms nor the contents of the sand boxes.
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •born in Finland
- •spends daily (5 d a week) several hours in one of the daycares in which the trial was performed
排除标准
- •medication affecting immune system function
- •medication affecting microbiota
- •immune deficiency
- •living on a farm
- •not born in Finland
研究组 & 干预措施
Placebo
Children were in contact with normal but colored sand that looked as it were the biodiversity sand. All the other details were as above.
干预措施: Placebo (Other)
Intervention
The children were in daily contact with biodiversity sand 5 days a week for two weeks.
干预措施: Biodiversity powder (Other)
结局指标
主要结局
Change in Interleukin 10 level in blood
时间窗: two weeks
The difference between day 0 and a follow up day in intervention
次要结局
- changes in tgf-beta levels(two weeks)
- ratio il-10 / il-17(two weeks)
- long-term changes in microbiota(four weeks)
- changes in microbiota(two weeks)
- changes in interleukin 17 levels(two weeks)
研究者
Aki Sinkkonen
University Researcher
University of Helsinki