Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis (BIWE)

Natural Resources Institute Finland

Status: Enrolling

Conditions: Atopic Dermatitis; Immune System and Related Disorders; Microbial Colonization; Nature, Human

Treatments: Biological: Microbial intervention; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06390696

R22127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eczema Area and Severity Index ≥ 2

Exclusion criteria

• Eczema Area and Severity Index < 2
• Immune deficiencies, i.e., antibody deficiency
• Immunosuppressive systematic medications
• A disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)
• Cancer diagnosis
• Topical medication for the treatment of atopic dermatitis during the trial
• Disability affecting the immune response (e.g. Down's syndrome)
• Non-participation in the national vaccine program
• Participation in another intervention or follow-up study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Microbial intervention

Experimental group

Description:

Children receive an indoor sandbox and cultivation set including soil- and plant-based material with high microbial diversity.

Treatment:

Biological: Microbial intervention

placebo

Placebo Comparator group

Description:

Children receive an indoor sandbox and cultivation set including placebo material with low microbial diversity.

Treatment:

Other: Placebo