Nationwide Research on the Rewilding of Kindergarten Yards

Not Applicable

Recruiting

• Conditions: Cognitive Change; Microbial Colonization; Asthma in Children; Allergy; Atopic Dermatitis; Respiratory Infection; Nature, Human

• Registration Number: NCT06390878
• Lead Sponsor: Natural Resources Institute Finland

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Study Start: 2024-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Attendance in kindergarten

Exclusion Criteria

• Use of antibiotics in the year before sampling

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skin Gammaproteobacteria	Baseline, 3 month, 1 year, 2 year, 3 year	Difference on skin gammaproteobacterial diversity between rewilding and control group

Secondary Outcome Measures

Name	Time	Method
Difference in taxonomies of skin, saliva and stool microbiota	Baseline, 3 month, 1 year, 2 year, 3 year	It will be analyzed if microbial communities are different between treatments
White blood cell distribution	Baseline, 3 month, 1 year, 2 year, 3 year	It will be analyzed if the distribution is different between treatments
Cortisol levels	Baseline, 3 month, 1 year, 2 year, 3 year	Cortisol levels measured from hair samples
Microbial observed species richness	Baseline, 3 month, 1 year, 2 year, 3 year	Higher score in observed species richness of commensal microbiota among biodiversity treatment
Infectious diseases	Baseline, 3 month, 1 year, 2 year, 3 year	Infections will be recorded with questionnaires.
Asthma symptoms	Baseline, 3 month, 1 year, 2 year, 3 year	Asthma symptoms will be recorded with questionnaires.
Allergy	Baseline, 3 month, 1 year, 2 year, 3 year	Allergies will be recorded with questionnaires.
Patient-oriented Eczema Measure	Baseline, 3 month, 1 year, 2 year, 3 year	Lower score on patient-oriented Eczema Measure among intervention treatment compared to control that indicates lower eczema among intervention treatment. Minimum 0, maximum 28.
White blood cell transcriptomics	Baseline, 3 month, 1 year, 2 year, 3 year	White blood cell transcriptome is analyzed with single cell RNA sequencing.
Skin cytokines	Baseline, 3 month, 1 year, 2 year, 3 year	Cytokines will be analyzed using skin tape strip samples.
Difference in diversity of skin, saliva and stool microbiota	Baseline, 3 month, 1 year, 2 year, 3 year	It will be analyzed if microbial communities are different between treatments
Atopic dermatitis	Baseline, 3 month, 1 year, 2 year, 3 year	Atopic dermatitis will be recorded with questionnaires.
Plasma cytokines	Baseline, 3 month, 1 year, 2 year, 3 year	Cytokines will be analyzed analyzed with Meso Scale.
Wechsler Preschool and Primary Scale of Intelligence	Baseline, 3 month, 1 year, 2 year, 3 year	Higher score on Wechsler Preschool and Primary Scale of Intelligence among intervention treatment compared to control that indicates better cognitive skills among intervention treatment. Minimum 40, maximum 170.

Trial Locations

Locations (2)

Natural Resources Institute Finland; 🇫🇮 Helsinki, Uusimaa, Finland

Tampere University; 🇫🇮 Tampere, Finland