Atopic Dermatitis, Immune System and Related Disorders, Microbial Colonization, Nature, Human
Conditions
Keywords
Atopy, Biodiversity, Commensal microbiota, Microbial exposure
Brief summary
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
BIOLOGICALMicrobial 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.
OTHERPlacebo
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.
Sponsors
Tampere University
Natural Resources Institute Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Saliva microbiota | Baseline, 2 month, 6 month | It will be analyzed if saliva microbial communities are different between treatments |
| Gut microbiota | Baseline, 2 month, 6 month | It will be analyzed if stool microbial communities are different between treatments |
| Infectious diseases | Baseline, 2 month, 6 month | Infections will be recorded with questionnaires. |
| The Patient-Oriented Eczema Measure | 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. |
| Allergy specific Immunoglobulin E | Baseline, 2 month, 6 month | It will be analyzed if allergy specific IgE is different between treatments |
| Plasma cytokines | Baseline, 2 month, 6 month | Cytokines will be analyzed analyzed with Meso Scale. |
| Depression Scale | 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. |
| Nature Relatedness Scale | 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. |
| Distribution of white blood cells | Baseline, 2 month, 6 month | It will be analyzed if the distribution is different between treatments |
| Skin microbiota | Baseline, 2 month, 6 month | It will be analyzed if skin microbial communities are different between treatments |
| Perceived Stress Scale | 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. |
| Warwick-Edinburgh Mental Wellbeing Scale | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Association between atopic dermatitis and skin microbiota. | 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. |
| Association between commensal microbiota and other outcomes. | 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. |
Countries
Finland
Contacts
Primary ContactSanna Hurtola
Outcome results
None listed