Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 320
- Locations
- 3
- Primary Endpoint
- Skin Gammaproteobacteria
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Attendance in kindergarten
Exclusion Criteria
- •Use of antibiotics in the year before sampling
Outcomes
Primary Outcomes
Skin Gammaproteobacteria
Time Frame: Baseline, 3 month, 1 year, 2 year, 3 year
Difference on skin gammaproteobacterial diversity between rewilding and control group
Secondary Outcomes
- 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)