Clinical trial

Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu

Name

R24023

Description

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).

Trial arms

Trial start

2024-05-01

Estimated PCD

2027-08-30

Trial end

2027-08-30

Status

Recruiting

Treatment

Biodiversity

In rewilding kindergartens, the yards are modified with biological elements, i.e., vegetation and plantation will be added to the yards.

Arms:

Rewilding

Playground equipment

Playground equipment that increase the physical activity of children will be added to the kindergarten yards.

Arms:

Control

Size

320

Primary endpoint

Skin Gammaproteobacteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 320, 'type': 'ESTIMATED'}}

Updated at

2024-04-30

1 organization

1 product

8 indications

Organization

Natural Resources Institute Finland

Product

Biodiversity

Indication

Microbial Colonization

Indication