Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microbial intervention, Placebo.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Nature, Human, Microbial Colonization, Immune System and Related Disorders. Basic parameters: 2 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biodiversity Interventions for Well-being - the Effect of Biodiversity Exposure on Atopic Dermatitis
Overview
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.
Interventions
- 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.
Primary outcome measures
- Eczema Area and Severity Index (EASI) [Time frame: Baseline, 2 month, 6 month]
Secondary outcome measures (12)
- The Patient-Oriented Eczema Measure [Time frame: Baseline, 2 month, 6 month]
- Allergy specific Immunoglobulin E [Time frame: Baseline, 2 month, 6 month]
- Plasma cytokines [Time frame: Baseline, 2 month, 6 month]
- Distribution of white blood cells [Time frame: Baseline, 2 month, 6 month]
- Skin microbiota [Time frame: Baseline, 2 month, 6 month]
- Saliva microbiota [Time frame: Baseline, 2 month, 6 month]
- Gut microbiota [Time frame: Baseline, 2 month, 6 month]
- Infectious diseases [Time frame: Baseline, 2 month, 6 month]
- Perceived Stress Scale [Time frame: Baseline, 2 month, 6 month]
- Warwick-Edinburgh Mental Wellbeing Scale [Time frame: Baseline, 2 month, 6 month]
- Depression Scale [Time frame: Baseline, 2 month, 6 month]
- Nature Relatedness Scale [Time frame: Baseline, 2 month, 6 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Finland · 2 centers
- Natural Resources Institute Finland — Helsinki
- Tampere University — Tampere
Identifiers
NCT: NCT06390696 · R22127