Clinical trial NCT06390878: Nationwide Research on the Rewilding of Kindergarten Yards
Official title: Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microbial Colonization
Atopic Dermatitis
Asthma in Children
Allergy
Cognitive Change
Respiratory Infection
Nature, Human
Keywords: Commensal microbiome
Atopy
Planetary health
Biodiversity
Cognitive skills
Lead sponsor: Natural Resources Institute Finland
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University
First posted: 2024-04-30
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* Attendance in kindergarten

Exclusion Criteria:

* Use of antibiotics in the year before sampling

Primary outcomes:
measure: Skin Gammaproteobacteria
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
Secondary outcomes:
measure: Cortisol levels
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Difference in diversity of skin, saliva and stool microbiota
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Microbial observed species richness
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Difference in taxonomies of skin, saliva and stool microbiota
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: White blood cell distribution
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: White blood cell transcriptomics
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Plasma cytokines
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Skin cytokines
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Infectious diseases
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Asthma symptoms
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Atopic dermatitis
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Allergy
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Patient-oriented Eczema Measure
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Wechsler Preschool and Primary Scale of Intelligence
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
Other outcomes:
measure: Associations between environmental factors and cytokine levels.
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and commensal microbiota.
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and white blood cells
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and cortisol levels
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and cognitive skills.
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and infectious diseases.
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and atopy.
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and allergies.
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
measure: Associations between environmental factors and asthma.
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year
Locations:
city: Helsinki
country: Finland
facility: Natural Resources Institute Finland
state: Uusimaa
city: Tampere
country: Finland
facility: Tampere University
Study officials:
affiliation: Natural Resources Institute Finland
name: Aki Sinkkonen
role: PRINCIPAL_INVESTIGATOR
References: