NCT Number: NCT06390696
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.
Interested in participating?
Request Info2 year–5 year
All sexes
Interventional
Not applicable
Natural Resources Institute Finland, Helsinki, Uusimaa, Finland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 2 month, 6 month
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 month
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 month
It will be analyzed if allergy specific IgE is different between treatments
Time frame: Baseline, 2 month, 6 month
Cytokines will be analyzed analyzed with Meso Scale.
Time frame: Baseline, 2 month, 6 month
It will be analyzed if the distribution is different between treatments
Time frame: Baseline, 2 month, 6 month
It will be analyzed if skin microbial communities are different between treatments
Time frame: Baseline, 2 month, 6 month
It will be analyzed if saliva microbial communities are different between treatments
Time frame: Baseline, 2 month, 6 month
It will be analyzed if stool microbial communities are different between treatments
Time frame: Baseline, 2 month, 6 month
Infections will be recorded with questionnaires.
Time frame: Baseline, 2 month, 6 month
Lower score on a perceived stress scale among guardians in intervention arm compared to placebo arm that indicates lower perceived stress levels among guardians in intervention arm. Minimum 0, maximum 40.
Time frame: Baseline, 2 month, 6 month
Higher score on a Warwick-Edinburhg Mental Wellbeing scale among guardians in intervention arm compared to placebo arm that indicates better mental well-being among guardians in intervention arm. Minimum 14, maximum 70.
Time frame: Baseline, 2 month, 6 month
Lower score on a Depression scale among guardians in intervention arm compared to placebo arm that indicates lower levels of depression symptoms among guardians in intervention arm. Minimum 0, maximum 60.
Time frame: Baseline, 2 month, 6 month
Higher score on a Nature Relatedness scale among guardians in intervention arm compared to placebo arm that indicates stronger sense of connectedness to nature among intervention arm. Minimum 6, maximum 30.
Time frame: Baseline, 2 month, 6 month
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 month
It will be assessed if commensal microbiota on skin, saliva or gut are associated with plasma cytokines, IgE or white blood cell distribution.
Contact information is provided by the study sponsor or research team.
Natural Resources Institute Finland
Other Gov
Biodiversity Interventions for Well-being - the Effect of Biodiversity Exposure on Atopic Dermatitis
Acronym: BIWE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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