Microbial ColonizationVahvistuNCT06390878
Nationwide Research on the Rewilding of Kindergarten Yards
A study testing Biodiversity and Playground equipment in people with Microbial Colonization and Atopic Dermatitis, run by Natural Resources Institute Finland at 2 sites in Finland.
Trial summary
Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities that is associated with altered commensal microbiota and a rising burden of immunological disorders among urban children. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Atopic Dermatitis, Asthma in Children
- What is being tested?
- Biodiversity and Playground equipment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesFinland
- Study dates
- 15 May 2024to 30 Aug 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attendance in kindergarten
Who cannot join
- Use of antibiotics in the year before sampling
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: Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu
Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities that is associated with altered commensal microbiota and a rising burden of immunological disorders among urban children.
The investigators will estimate how rewilding of kindergarten yards affects commensal microbiome, prevalence of allergies, asthma, atopic dermatitis and infections, cortisol levels, cognitive skills and plasma cytokine levels of children.
Read more
Our specific aims are:
To assess if rewilding diversifies health-associated skin, saliva and gut microbiota and reduces infectious diseases and atopic or allergic symptoms.
Assess whether the rewilding has positive effects on cognitive skills. Assess whether the rewilding changes cortisol and plasma cytokine levels. The investigators will recruit altogether 320 (160 per treatment) study subjects aged between 1-5 to questionnaire study (Task 2), from which 120 study subjects will be analyzed more detailed using microbiological and blood samples (Task 1).
- Conditions
- Microbial Colonization, Atopic Dermatitis, Asthma in Children, Allergy, Cognitive Change, Respiratory Infection
- Being tested
- Biodiversity, Playground equipment
- Keywords
- Commensal microbiome, Atopy, Planetary health, Biodiversity, Cognitive skills
- Medical subject headings
- Communicable Diseases, Dermatitis, Atopic, Hypersensitivity, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodiversityOther
In rewilding kindergartens, the yards are modified with biological elements, i.e., vegetation and plantation will be added to the yards.
Playground equipmentOther
Playground equipment that increase the physical activity of children will be added to the kindergarten yards.
| Study group | Role | What they receive |
|---|---|---|
| Rewilding | Experimental | The kindergarten yards are modified with natural elements to increase children's exposure to biodiversity and playground equipment are incorporated to the yards to increase children's physical activity. Receives: Other: Biodiversity |
| Control | Experimental | The kindergarten yards are not rewilded with natural elements and the biodiversity is low at the yards. Playground equipment are incorporated to the yards to increase children's physical activity. Receives: Other: Playground equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Gammaproteobacteria
Difference on skin gammaproteobacterial diversity between rewilding and control group
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Secondary outcomes (14)
Cortisol levels
Cortisol levels measured from hair samples
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Difference in diversity of skin, saliva and stool microbiota
It will be analyzed if microbial communities are different between treatments
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Microbial observed species richness
Higher score in observed species richness of commensal microbiota among biodiversity treatment
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Difference in taxonomies of skin, saliva and stool microbiota
It will be analyzed if microbial communities are different between treatments
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
White blood cell distribution
It will be analyzed if the distribution is different between treatments
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
White blood cell transcriptomics
White blood cell transcriptome is analyzed with single cell RNA sequencing.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Plasma cytokines
Cytokines will be analyzed analyzed with Meso Scale.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Skin cytokines
Cytokines will be analyzed using skin tape strip samples.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Infectious diseases
Infections will be recorded with questionnaires.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Asthma symptoms
Asthma symptoms will be recorded with questionnaires.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Atopic dermatitis
Atopic dermatitis will be recorded with questionnaires.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Allergy
Allergies will be recorded with questionnaires.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Patient-oriented Eczema Measure
Lower score on patient-oriented Eczema Measure among intervention treatment compared to control that indicates lower eczema among intervention treatment. Minimum 0, maximum 28.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
Wechsler Preschool and Primary Scale of Intelligence
Higher score on Wechsler Preschool and Primary Scale of Intelligence among intervention treatment compared to control that indicates better cognitive skills among intervention treatment. Minimum 40, maximum 170.
Measured: Baseline, 3 month, 1 year, 2 year, 3 year
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 start15 May 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Resources Institute Finland
- Sponsor type
- Other government
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Aki Sinkkonen, Principal investigator, Natural Resources Institute Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390878
- Sponsor's protocol ID
- R24023
- Acronym
- Vahvistu
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 24 Jun 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Research on the Rewilding of Kindergarten Yards - Vahvistu
- ClinicalTrials.gov ID
- NCT06390878
- Acronym / sponsor ID
- Vahvistu / R24023
- Conditions
- Microbial Colonization, Atopic Dermatitis, Asthma in Children, Allergy, Cognitive Change, Respiratory Infection
- Keywords
- Commensal microbiome, Atopy, Planetary health, Biodiversity, Cognitive skills
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Natural Resources Institute FinlandOther government
- Collaborators
- Tampere University
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 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.
Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities that is associated with altered commensal microbiota and a rising burden of immunological disorders among urban children.
The investigators will estimate how rewilding of kindergarten yards affects commensal microbiome, prevalence of allergies, asthma, atopic dermatitis and infections, cortisol levels, cognitive skills and plasma cytokine levels of children.
Our specific aims are:
To assess if rewilding diversifies health-associated skin, saliva and gut microbiota and reduces infectious diseases and atopic or allergic symptoms.
Assess whether the rewilding has positive effects on cognitive skills. Assess whether the rewilding changes cortisol and plasma cytokine levels. The investigators will recruit altogether 320 (160 per treatment) study subjects aged between 1-5 to questionnaire study (Task 2), from which 120 study subjects will be analyzed more detailed using microbiological and blood samples (Task 1).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rewilding | Experimental | Other: BiodiversityThe kindergarten yards are modified with natural elements to increase children's exposure to biodiversity and playground equipment are incorporated to the yards to increase children's physical activity. |
| Control | Experimental | Other: Playground equipmentThe kindergarten yards are not rewilded with natural elements and the biodiversity is low at the yards. Playground equipment are incorporated to the yards to increase children's physical activity. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attendance in kindergarten
Key exclusion criteria (1 listed)
- Use of antibiotics in the year before sampling
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 |
|---|---|---|
| BiodiversityIn rewilding kindergartens, the yards are modified with biological elements, i.e., vegetation and plantation will be added to the yards. | Other | Rewilding |
| Playground equipmentPlayground equipment that increase the physical activity of children will be added to the kindergarten yards. | Other | Control |
Primary outcome
Skin Gammaproteobacteria
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Difference on skin gammaproteobacterial diversity between rewilding and control group
14 secondary outcomes
Cortisol levels
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Difference in diversity of skin, saliva and stool microbiota
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Microbial observed species richness
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Difference in taxonomies of skin, saliva and stool microbiota
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
White blood cell distribution
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
White blood cell transcriptomics
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Plasma cytokines
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Skin cytokines
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Infectious diseases
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Asthma symptoms
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Atopic dermatitis
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Allergy
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Patient-oriented Eczema Measure
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
Wechsler Preschool and Primary Scale of Intelligence
Time frame: Baseline, 3 month, 1 year, 2 year, 3 year
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 24 Jun 2024.
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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 Biodiversity and Playground equipment in people with Microbial Colonization and Atopic Dermatitis, 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 1 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 24 Jun 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. 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?
Skin Gammaproteobacteria (time frame: Baseline, 3 month, 1 year, 2 year, 3 year). 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 24 Jun 2024.