NCT06390696

Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis

Biodiversity Interventions for Well-being - the Effect of Biodiversity Exposure on Atopic Dermatitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Natural Resources Institute Finland · Other Government
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Accepted

Summary

The prevalence of atopic dermatitis has increased along with urbanization and biodiversity loss. According to biodiversity hypothesis, the main reason is urban lifestyle and reduced contact to microbial diversity. Previous studies indicate association between atopic dermatitis and exposure to natural microbes in childhood. Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis will investigate whether the exposure to microbial diversity in sandbox reduces the symptoms of atopic dermatitis, alters commensal microbiota and modifies immune regulation in children.

Detailed description

Our specific aims are: To assess if exposure to microbial diversity reduces Eczema Area and Severity Index (EASI) and Patient-Oriented Eczema Measure (POEM). Assess whether the sand play alters plasma cytokine profiles, white blood cell distributions, allergy specific IgE, and commensal microbial communities on skin, in saliva and gut. The investigators will recruit approximately 80 (40 study subjects per treatment) subjects with atopic dermatitis and aged between 2-5.

Conditions

• Atopic Dermatitis
• Nature, Human
• Microbial Colonization
• Immune System and Related Disorders

Interventions

Type	Name	Description
BIOLOGICAL	Microbial intervention	Children in microbial intervention arm receive an indoor sandbox containing play sand enriched with organic leaf compost, moss and humus substances. Families also receive an indoor cultivation set including growing box, seeds, spray bottle, plant lamp and microbe rich growing medium containing organic leaf compost, moss, biochar and humus substances.
OTHER	Placebo	Children in placebo arm receive an indoor sandbox containing visually similar play sand modified with peat with low microbial diversity. Families also receive an indoor cultivation set including growing box, seeds, spray bottle, plant lamp and growing medium containing peat, inorganic fertilizers, and potting gravel with low microbial diversity.

Timeline

• Start date: 2023-05-26
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

2 sites across 1 country: Finland