Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— BIWE  

Official title:

Biodiversity Interventions for Well-being - the Effect of Biodiversity Exposure on Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390696
• Other study ID #: R22127
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: April 2024
• Source: Natural Resources Institute Finland
• Contact: Sanna Hurtola
• Phone: +358295322500
• Email: sanna.hurtola[@]luke.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Communicable Diseases
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Immune System and Related Disorders
• Infections
• Microbial Colonization

Intervention

Biological:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Finland	Natural Resources Institute Finland	Helsinki	Uusimaa
Finland	Tampere University	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Natural Resources Institute Finland	Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, 2 month, 6 month
Other	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.	Baseline, 2 month, 6 month
Primary	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.	Baseline, 2 month, 6 month
Secondary	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.	Baseline, 2 month, 6 month
Secondary	Allergy specific Immunoglobulin E	It will be analyzed if allergy specific IgE is different between treatments	Baseline, 2 month, 6 month
Secondary	Plasma cytokines	Cytokines will be analyzed analyzed with Meso Scale.	Baseline, 2 month, 6 month
Secondary	Distribution of white blood cells	It will be analyzed if the distribution is different between treatments	Baseline, 2 month, 6 month
Secondary	Skin microbiota	It will be analyzed if skin microbial communities are different between treatments	Baseline, 2 month, 6 month
Secondary	Saliva microbiota	It will be analyzed if saliva microbial communities are different between treatments	Baseline, 2 month, 6 month
Secondary	Gut microbiota	It will be analyzed if stool microbial communities are different between treatments	Baseline, 2 month, 6 month
Secondary	Infectious diseases	Infections will be recorded with questionnaires.	Baseline, 2 month, 6 month
Secondary	Perceived Stress Scale	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.	Baseline, 2 month, 6 month
Secondary	Warwick-Edinburgh Mental Wellbeing Scale	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.	Baseline, 2 month, 6 month
Secondary	Depression Scale	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.	Baseline, 2 month, 6 month
Secondary	Nature Relatedness Scale	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.	Baseline, 2 month, 6 month