Clinical trial NCT06390696: Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis
Official title: Biodiversity Interventions for Well-being - the Effect of Biodiversity Exposure on Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Nature, Human
Microbial Colonization
Immune System and Related Disorders
Keywords: Atopy
Biodiversity
Commensal microbiota
Microbial exposure
Lead sponsor: Natural Resources Institute Finland
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University
First posted: 2024-04-30
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: Baseline, 2 month, 6 month
Secondary outcomes:
measure: The Patient-Oriented Eczema Measure
timeFrame: Baseline, 2 month, 6 month
measure: Allergy specific Immunoglobulin E
timeFrame: Baseline, 2 month, 6 month
measure: Plasma cytokines
timeFrame: Baseline, 2 month, 6 month
measure: Distribution of white blood cells
timeFrame: Baseline, 2 month, 6 month
measure: Skin microbiota
timeFrame: Baseline, 2 month, 6 month
measure: Saliva microbiota
timeFrame: Baseline, 2 month, 6 month
measure: Gut microbiota
timeFrame: Baseline, 2 month, 6 month
measure: Infectious diseases
timeFrame: Baseline, 2 month, 6 month
measure: Perceived Stress Scale
timeFrame: Baseline, 2 month, 6 month
measure: Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: Baseline, 2 month, 6 month
measure: Depression Scale
timeFrame: Baseline, 2 month, 6 month
measure: Nature Relatedness Scale
timeFrame: Baseline, 2 month, 6 month
Other outcomes:
measure: Association between atopic dermatitis and skin microbiota.
timeFrame: Baseline, 2 month, 6 month
measure: Association between commensal microbiota and other outcomes.
timeFrame: Baseline, 2 month, 6 month
Locations:
city: Helsinki
country: Finland
facility: Natural Resources Institute Finland
state: Uusimaa
city: Tampere
country: Finland
facility: Tampere University
Study officials:
affiliation: Natural Resources Institute Finland
name: Aki Sinkkonen
role: PRINCIPAL_INVESTIGATOR
References: