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Recruiting NCT06390878

Nationwide Research on the Rewilding of Kindergarten Yards

No phase Interventional Microbial Colonization Atopic Dermatitis Asthma in Children Allergy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biodiversity, Playground equipment.
Who it may be relevant to
Registry conditions: Microbial Colonization, Atopic Dermatitis, Asthma in Children, Allergy. Basic parameters: 1 year — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu

Overview

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).

Interventions

  • Other Biodiversity
    In rewilding kindergartens, the yards are modified with biological elements, i.e., vegetation and plantation will be added to the yards.
  • Other Playground equipment
    Playground equipment that increase the physical activity of children will be added to the kindergarten yards.

Primary outcome measures

  • Skin Gammaproteobacteria [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
Secondary outcome measures (12)
  • Cortisol levels [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Difference in diversity of skin, saliva and stool microbiota [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Microbial observed species richness [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Difference in taxonomies of skin, saliva and stool microbiota [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • White blood cell distribution [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • White blood cell transcriptomics [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Plasma cytokines [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Skin cytokines [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Infectious diseases [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Asthma symptoms [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Atopic dermatitis [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]
  • Allergy [Time frame: Baseline, 3 month, 1 year, 2 year, 3 year]

Eligibility criteria

Inclusion criteria

  • Attendance in kindergarten

Exclusion criteria

  • Use of antibiotics in the year before sampling

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Finland · 2 centers
  • Natural Resources Institute Finland — Helsinki
  • Tampere University — Tampere

Identifiers

NCT: NCT06390878 · R24023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗