Nationwide Research on the Rewilding of Kindergarten Yards

Atopic Dermatitis Clinical Trial

— Vahvistu  

Official title:

Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390878
• Other study ID #: R24023
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 30, 2027

Study information

• Verified date: April 2024
• Source: Natural Resources Institute Finland
• Contact: Sanna Hurtola
• Phone: +358295322500
• Email: sanna.hurtola[@]luke.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• Attendance in kindergarten

Exclusion Criteria:

• Use of antibiotics in the year before sampling

Related Conditions & MeSH terms

• Allergy
• Asthma in Children
• Atopic Dermatitis
• Cognitive Change
• Communicable Diseases
• Dermatitis
• Infections
• Microbial Colonization
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Finland	Natural Resources Institute Finland	Helsinki	Uusimaa
Finland	Tampere University	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Natural Resources Institute Finland	Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Associations between environmental factors and primary and secondary outcomes.	Associations between environmental factors (vegetation, deadwood, and polypore richness, land cover categories and other yard characteristics) and cytokine levels, microbial measurements, white blood cell transcriptome and distribution, cortisol levels, cognitive skills, the prevalence of infectious diseases and atopy, allergy and asthma symptoms.	Baseline, 3 month, 1 year, 2 year, 3 year
Primary	Skin Gammaproteobacteria	Difference on skin gammaproteobacterial diversity between rewilding and control group	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Cortisol levels	Cortisol levels measured from hair samples	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Difference in diversity of skin, saliva and stool microbiota	It will be analyzed if microbial communities are different between treatments	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Difference in observed species richness of skin, saliva and stool microbiota	It will be analyzed if microbial communities are different between treatments	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Difference in taxonomies of skin, saliva and stool microbiota	It will be analyzed if microbial communities are different between treatments	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Distribution of white blood cells	It will be analyzed if the distribution is different between treatments	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	White blood cell transcriptomics	White blood cell transcriptome is analyzed with single cell RNA sequencing.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Plasma cytokines	Cytokines will be analyzed analyzed with Meso Scale.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Skin cytokines	Cytokines will be analyzed using skin tape strip samples.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Infectious diseases	Infections will be recorded with questionnaires.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Asthma symptoms	Asthma symptoms will be recorded with questionnaires.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Atopic dermatitis	Atopic dermatitis will be recorded with questionnaires.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Allergy	Allergies will be recorded with questionnaires.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Patient-oriented Eczema Measure	Lower score on patient-oriented Eczema Measure among intervention treatment compared to control that indicates lower eczema among intervention treatment. Minimum 0, maximum 28.	Baseline, 3 month, 1 year, 2 year, 3 year
Secondary	Wechsler Preschool and Primary Scale of Intelligence	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.	Baseline, 3 month, 1 year, 2 year, 3 year