Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorNatural Resources Institute Finland
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Eczema Area and Severity Index ≥ 2
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Microbial intervention
Biological/VaccineChildren 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
Other interventionChildren 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Microbial interventionExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Eczema Area and Severity Index (EASI)
EASI reduced by at least 50% from baseline in microbial intervention treatment. The minimum EASI score is 0 and the maximum EASI score is 72.
Time frame
Baseline, 2 month, 6 monthSecondary outcomes
1
The Patient-Oriented Eczema Measure
Lower score on the Patient-Oriented Eczema Measure (POEM) among microbial intervention arm compared to placebo arm after intervention. The total POEM score can range from 0 to 28, with higher scores indicating more severe eczema symptoms.
Time frame
Baseline, 2 month, 6 month2
Allergy specific Immunoglobulin E
It will be analyzed if allergy specific IgE is different between treatments
Time frame
Baseline, 2 month, 6 month3
Plasma cytokines
Cytokines will be analyzed analyzed with Meso Scale.
Time frame
Baseline, 2 month, 6 month4
Distribution of white blood cells
It will be analyzed if the distribution is different between treatments
Time frame
Baseline, 2 month, 6 monthOther outcomes
1
Association between atopic dermatitis and skin microbiota.
It will be assessed if changes in skin microbiota are associated with Eczema Area and Severity Index and the Patient-Oriented Eczema Measure.
Time frame
Baseline, 2 month, 6 month2
Association between commensal microbiota and other outcomes.
It will be assessed if commensal microbiota on skin, saliva or gut are associated with plasma cytokines, IgE or white blood cell distribution.
Time frame
Baseline, 2 month, 6 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Natural Resources Institute Finland
Lead sponsor
Tampere University
Collaborator
Source ClinicalTrials.gov