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临床试验/NCT06390878
NCT06390878招募中不适用

Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu

Natural Resources Institute Finland3 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
320
试验地点
3
主要终点
Skin Gammaproteobacteria

研究概览

简要总结

Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities that is associated with altered commensal microbiota and a rising burden of immunological disorders among urban children.

The investigators will estimate how rewilding of kindergarten yards affects commensal microbiome, prevalence of allergies, asthma, atopic dermatitis and infections, cortisol levels, cognitive skills and plasma cytokine levels of children.

Our specific aims are:

To assess if rewilding diversifies health-associated skin, saliva and gut microbiota and reduces infectious diseases and atopic or allergic symptoms.

Assess whether the rewilding has positive effects on cognitive skills. Assess whether the rewilding changes cortisol and plasma cytokine levels. The investigators will recruit altogether 320 (160 per treatment) study subjects aged between 1-5 to questionnaire study (Task 2), from which 120 study subjects will be analyzed more detailed using microbiological and blood samples (Task 1).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Attendance in kindergarten

排除标准

  • Use of antibiotics in the year before sampling

结局指标

主要结局

Skin Gammaproteobacteria

时间窗: Baseline, 3 month, 1 year, 2 year, 3 year

Difference on skin gammaproteobacterial diversity between rewilding and control group

次要结局

  • Difference in taxonomies of skin, saliva and stool microbiota(Baseline, 3 month, 1 year, 2 year, 3 year)
  • White blood cell distribution(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Cortisol levels(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Microbial observed species richness(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Infectious diseases(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Asthma symptoms(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Allergy(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Patient-oriented Eczema Measure(Baseline, 3 month, 1 year, 2 year, 3 year)
  • White blood cell transcriptomics(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Skin cytokines(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Difference in diversity of skin, saliva and stool microbiota(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Atopic dermatitis(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Plasma cytokines(Baseline, 3 month, 1 year, 2 year, 3 year)
  • Wechsler Preschool and Primary Scale of Intelligence(Baseline, 3 month, 1 year, 2 year, 3 year)

研究者

发起方
Natural Resources Institute Finland
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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