Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis (BIWE)

April 25, 2024 updated by: Aki Sinkkonen, Natural Resources Institute Finland

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Tampere, Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00970
        • Recruiting
        • Natural Resources Institute Finland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microbial intervention
Children receive an indoor sandbox and cultivation set including soil- and plant-based material with high microbial diversity.
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.
Placebo Comparator: placebo
Children receive an indoor sandbox and cultivation set including placebo material with low microbial diversity.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema Area and Severity Index (EASI)
Time Frame: 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.
Baseline, 2 month, 6 month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between atopic dermatitis and skin microbiota.
Time Frame: 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.
Baseline, 2 month, 6 month
Association between commensal microbiota and other outcomes.
Time Frame: 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.
Baseline, 2 month, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Resources Institute Finland

Collaborators

Tampere University

Investigators

  • Principal Investigator: Aki Sinkkonen, Natural Resources Institute Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R22127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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