Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis

NCT06390696 | Recruiting

• 1 other identifier: R22127
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis; Nature, Human; Microbial Colonization; Immune System and Related Disorders

Keywords

Atopy; Biodiversity; Commensal microbiota; Microbial exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• The Patient-Oriented Eczema Measure

  Baseline, 2 month, 6 month

• Allergy specific Immunoglobulin E

  Baseline, 2 month, 6 month

• Plasma cytokines

  Baseline, 2 month, 6 month

• Distribution of white blood cells

  Baseline, 2 month, 6 month

• Skin microbiota

  Baseline, 2 month, 6 month

Other Outcomes (2)

• Association between atopic dermatitis and skin microbiota.

  Baseline, 2 month, 6 month

• Association between commensal microbiota and other outcomes.

  Baseline, 2 month, 6 month

Study Arms (2)

Microbial intervention

EXPERIMENTAL

Children receive an indoor sandbox and cultivation set including soil- and plant-based material with high microbial diversity.

Biological: Microbial intervention

placebo

PLACEBO COMPARATOR

Children receive an indoor sandbox and cultivation set including placebo material with low microbial diversity.

Other: Placebo

Interventions

Microbial intervention BIOLOGICAL

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.

Microbial intervention

Placebo OTHER

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.

placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Eczema Area and Severity Index ≥ 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Natural Resources Institute Finland: lead
• Tampere University: collaborator

Study Sites (2)

Natural Resources Institute Finland

Helsinki, Uusimaa, 00970, Finland

RECRUITING

Tampere University

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Communicable Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aki Sinkkonen

  Natural Resources Institute Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanna Hurtola

CONTACT

+358295322500; sanna.hurtola@luke.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Researcher

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 26, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

FI (2)