Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis
NCT ID: NCT06390696
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-05-26
2027-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Microbial intervention
Children receive an indoor sandbox and cultivation set including soil- and plant-based material with high microbial diversity.
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.
placebo
Children receive an indoor sandbox and cultivation set including placebo material with low microbial diversity.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
2 Years
5 Years
ALL
Yes
Sponsors
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Tampere University
OTHER
Natural Resources Institute Finland
OTHER_GOV
Responsible Party
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Aki Sinkkonen
Lead Researcher
Principal Investigators
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Aki Sinkkonen
Role: PRINCIPAL_INVESTIGATOR
Natural Resources Institute Finland
Locations
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Natural Resources Institute Finland
Helsinki, Uusimaa, Finland
Tampere University
Tampere, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R22127
Identifier Type: -
Identifier Source: org_study_id
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