Atopic DermatitisBIWENCT06390696
Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis
A study testing Microbial intervention in people with Atopic Dermatitis and Nature, Human, run by Natural Resources Institute Finland at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Nature, Human, Microbial Colonization
- What is being tested?
- Microbial intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesFinland
- Study dates
- 26 May 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Eczema Area and Severity Index ≥ 2
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Natural Resources Institute Finland
Helsinki, Uusimaa, 00970
Marja Roslund, +358295322256, marja.roslund@luke.fi
- Recruiting
Tampere University
Tampere
Laura Kummola, Phd, laura.kummola@tuni.fi
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis, Nature, Human, Microbial Colonization, Immune System and Related Disorders
- Being tested
- Microbial intervention, Placebo
- Keywords
- Atopy, Biodiversity, Commensal microbiota, Microbial exposure
- Medical subject headings
- Dermatitis, Atopic, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbial interventionBiological
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Microbial intervention | Experimental | Children receive an indoor sandbox and cultivation set including soil- and plant-based material with high microbial diversity. Receives: Biological: Microbial intervention |
| placebo | Placebo comparator | Children receive an indoor sandbox and cultivation set including placebo material with low microbial diversity. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 month, 6 month
Secondary outcomes (12)
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.
Measured: Baseline, 2 month, 6 month
Allergy specific Immunoglobulin E
It will be analyzed if allergy specific IgE is different between treatments
Measured: Baseline, 2 month, 6 month
Plasma cytokines
Cytokines will be analyzed analyzed with Meso Scale.
Measured: Baseline, 2 month, 6 month
Distribution of white blood cells
It will be analyzed if the distribution is different between treatments
Measured: Baseline, 2 month, 6 month
Skin microbiota
It will be analyzed if skin microbial communities are different between treatments
Measured: Baseline, 2 month, 6 month
Saliva microbiota
It will be analyzed if saliva microbial communities are different between treatments
Measured: Baseline, 2 month, 6 month
Gut microbiota
It will be analyzed if stool microbial communities are different between treatments
Measured: Baseline, 2 month, 6 month
Infectious diseases
Infections will be recorded with questionnaires.
Measured: Baseline, 2 month, 6 month
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.
Measured: Baseline, 2 month, 6 month
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.
Measured: Baseline, 2 month, 6 month
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.
Measured: Baseline, 2 month, 6 month
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.
Measured: Baseline, 2 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start26 May 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Resources Institute Finland
- Sponsor type
- Other government
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Aki Sinkkonen, Natural Resources Institute Finland
- Investigators
- Aki Sinkkonen, Principal investigator, Natural Resources Institute Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390696
- Sponsor's protocol ID
- R22127
- Acronym
- BIWE
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodiversity Interventions for Well-being - the Effect of Biodiversity Exposure on Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06390696
- Acronym / sponsor ID
- BIWE / R22127
- Conditions
- Atopic Dermatitis, Nature, Human, Microbial Colonization, Immune System and Related Disorders
- Keywords
- Atopy, Biodiversity, Commensal microbiota, Microbial exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Natural Resources Institute FinlandOther government
- Collaborators
- Tampere University
- Study start
- 26 May 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbial intervention | Experimental | Biological: Microbial interventionChildren receive an indoor sandbox and cultivation set including soil- and plant-based material with high microbial diversity. |
| placebo | Placebo comparator | Other: PlaceboChildren receive an indoor sandbox and cultivation set including placebo material with low microbial diversity. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Eczema Area and Severity Index ≥ 2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbial interventionChildren 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. | Biological | Microbial intervention |
| PlaceboChildren 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. | Other | placebo |
Primary outcome
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.
12 secondary outcomes
The Patient-Oriented Eczema Measure
Time frame: Baseline, 2 month, 6 month
Allergy specific Immunoglobulin E
Time frame: Baseline, 2 month, 6 month
Plasma cytokines
Time frame: Baseline, 2 month, 6 month
Distribution of white blood cells
Time frame: Baseline, 2 month, 6 month
Skin microbiota
Time frame: Baseline, 2 month, 6 month
Saliva microbiota
Time frame: Baseline, 2 month, 6 month
Gut microbiota
Time frame: Baseline, 2 month, 6 month
Infectious diseases
Time frame: Baseline, 2 month, 6 month
Perceived Stress Scale
Time frame: Baseline, 2 month, 6 month
Warwick-Edinburgh Mental Wellbeing Scale
Time frame: Baseline, 2 month, 6 month
Depression Scale
Time frame: Baseline, 2 month, 6 month
Nature Relatedness Scale
Time frame: Baseline, 2 month, 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aki Sinkkonen principal investigator
Natural Resources Institute Finland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbial intervention in people with Atopic Dermatitis and Nature, Human, run by Natural Resources Institute Finland at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanna Hurtola (+358295322500, sanna.hurtola@luke.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: Baseline, 2 month, 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.