ADELE: Autoimmune Defense and Living Environment Acronym Description: Adele Comes From the Capitalized Words in the Following Words: Autoimmune DEfense and Living Environment
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diversity of Gammaproteobacteria on skin.
研究概览
简要总结
This study evaluates the effect of vegetation cover on certain Interleukin-10 and immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten that does not have forest floor and agricultural land in the backyards, or alternatively they will be in a kindergarten that does have forest floor and agricultural land in the backyards.
详细描述
High vegetation cover is assumed to change immunoglobulinE (IgE) and interleukin-10 concentrations in blood serum. Children living in high-green kindergarten are compared with those kindergarten living utilizing backyards with a low-green cover.
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
- None
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
- •children living in study kindergartens
排除标准
- •immune system deficiency, e.g. HIV-infection
- •a drug decreasing immune system response, e.g. oral corticosteroid
- •immune system disorder that affects immune response, e.g. rheumatoid
- •colitis ulcerosa, Crohn disease, diabetes
- •age less than 3 or more than 5
- •born outside Finland
- •intellectual disability
研究组 & 干预措施
City kindergarten
Children living in a normal city kindergarten that hardly has vegetation in backyards
adding of vegetation into the backyards.
Children living in a normal city kindergarten that has plenty of vegetation in backyards.
Intervention: adding of vegetation into the backyards.
干预措施: Adding of vegetation into the backyards of kindergarten (Other)
Nature kindergarten
Children living in a city kindergarten where children go regularly into a natural forest
结局指标
主要结局
Diversity of Gammaproteobacteria on skin.
时间窗: 28 days
Diversity of skin Gammaproteobacteria is higher in intervention arm compared to control arm and similar compared to nature-oriented arm after 28-day intervention. It will be measured at baseline and after 28-day intervention.
次要结局
- Skin bacterial community changes at phylum level(28 days)
- Stool bacterial community changes at phylum level(28 days)
- TGF-beta: IL-17A ratio in serum plasma(28 days)
- IL-17A change in serum plasma(28 days)
- TGF-beta change in serum plasma(28 days)
- IL-10 change in serum plasma(28 days)
- Skin bacterial community changes at class level(28 days)
- Skin bacterial community changes at order level(28 days)
- Skin bacterial community changes at family level are higher in intervention than control arm(28 days)
- Skin bacterial community changes at genus level(28 days)
- Associations between serum plasma TGF-beta and skin microbiota changes(28 days)
- Stool bacterial community changes at class level(28 days)
- Stool bacterial community changes at order level(28 days)
- Associations between serum plasma IL-10 and skin Gammaproteobacterial microbiota changes(28 days)
- Interleukin-10 : interleukin-17A ratio in serum plasma(28 days)
- Stool bacterial community changes at family level(28 days)
- Gut Faecalibacterium community changes(28 days)
- Associations between serum plasma IL-17 and skin Gammaproteobacterial microbiota changes(28 days)
研究者
Aki Sinkkonen
University researcher, docent
University of Helsinki