Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis

Not Applicable

Recruiting

• Conditions: Atopic Dermatitis; Nature, Human; Microbial Colonization; Immune System and Related Disorders
• Interventions: Other: Placebo; Biological: Microbial intervention

• Registration Number: NCT06390696
• Lead Sponsor: Natural Resources Institute Finland

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.

Study Timeline

• Study Start: 2023-05-26
• Status Verified: 2024-04
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Children receive an indoor sandbox and cultivation set including placebo material with low microbial diversity.
Microbial intervention	Microbial intervention	Children receive an indoor sandbox and cultivation set including soil- and plant-based material with high microbial diversity.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Plasma cytokines	Baseline, 2 month, 6 month	Cytokines will be analyzed analyzed with Meso Scale.
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
Allergy specific Immunoglobulin E	Baseline, 2 month, 6 month	It will be analyzed if allergy specific IgE is different between treatments
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.
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.
Skin microbiota	Baseline, 2 month, 6 month	It will be analyzed if skin microbial communities are different between treatments
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.
Distribution of white blood cells	Baseline, 2 month, 6 month	It will be analyzed if the distribution is different between treatments
Infectious diseases	Baseline, 2 month, 6 month	Infections will be recorded with questionnaires.
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.
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.

Trial Locations

Locations (2)

Tampere University; 🇫🇮 Tampere, Finland

Natural Resources Institute Finland; 🇫🇮 Helsinki, Uusimaa, Finland