Ige Responsiveness, AtopicADELEWP1t7NCT02733926
Effect of Vegetation in Kindergartens on the Immune Response of Children
A study testing Adding of vegetation into the backyards of kindergarten in people with Ige Responsiveness, Atopic, run by University of Helsinki at 1 site in Finland.
Trial summary
This study evaluates the effect of vegetation cover on certain Interleukin-10 and immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten that does not have forest floor and agricultural land in the backyards, or alternatively they will be in a kindergarten that does have forest… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Ige Responsiveness, Atopic
- What is being tested?
- Adding of vegetation into the backyards of kindergarten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children living in study kindergartens
Who cannot join
- immune system deficiency, e.g. HIV-infection
- a drug decreasing immune system response, e.g. oral corticosteroid
- immune system disorder that affects immune response, e.g. rheumatoid
- colitis ulcerosa, Crohn disease, diabetes
- cancer
- age less than 3 or more than 5
- born outside Finland
- intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADELE: Autoimmune Defense and Living Environment Acronym Description: Adele Comes From the Capitalized Words in the Following Words: Autoimmune DEfense and Living Environment
This study evaluates the effect of vegetation cover on certain Interleukin-10 and immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten that does not have forest floor and agricultural land in the backyards, or alternatively they will be in a kindergarten that does have forest floor and agricultural land in the backyards.
Read the detailed description
High vegetation cover is assumed to change immunoglobulinE (IgE) and interleukin-10 concentrations in blood serum. Children living in high-green kindergarten are compared with those kindergarten living utilizing backyards with a low-green cover.
- Conditions
- Ige Responsiveness, Atopic
- Being tested
- Adding of vegetation into the backyards of kindergarten
- Medical subject headings
- Ige Responsiveness, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding of vegetation into the backyards of kindergartenOther
Living plants are transferred into the backyards of kindergartens. This is assumed to affect the measured variables of children.
| Study group | Role | What they receive |
|---|---|---|
| City kindergarten | No intervention | Children living in a normal city kindergarten that hardly has vegetation in backyards |
| adding of vegetation into the backyards. | Experimental | Children living in a normal city kindergarten that has plenty of vegetation in backyards.
Intervention: adding of vegetation into the backyards. Receives: Other: Adding of vegetation into the backyards of kindergarten |
| Nature kindergarten | No intervention | Children living in a city kindergarten where children go regularly into a natural forest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diversity of Gammaproteobacteria on skin.
Diversity of skin Gammaproteobacteria is higher in intervention arm compared to control arm and similar compared to nature-oriented arm after 28-day intervention. It will be measured at baseline and after 28-day intervention.
Measured: 28 days
Secondary outcomes (18)
TGF-beta change in serum plasma
An increase in TGF-beta in intervention arm but not in control arm at the end of the 28 days intervention
Measured: 28 days
TGF-beta: IL-17A ratio in serum plasma
An increase in TGF-beta: IL17A ratio in intervention arm but not in control arm at the end of the 28 days intervention
Measured: 28 days
IL-10 change in serum plasma
An increase in IL-10 in intervention arm but not in control arm at the end of the 28 days intervention
Measured: 28 days
IL-17A change in serum plasma
A decrease in IL-17A in intervention arm but not in control arm at the end of the 28 days intervention
Measured: 28 days
Skin bacterial community changes at phylum level
Diversity of skin bacterial phyla, particularly Proteobacterial community, is higher in intervention arm compared to control arm. Proteobacterial community was associated with the coverage of green land cover in an earlier study. In addition, it was different in atopic and non-atopic study subjects in an earlier study. Diversity is measured as Shannon diversity index, Multivariate Homogeneity of Group Dispersions and the number of taxa (richness).
Measured: 28 days
Skin bacterial community changes at class level
Diversity of skin bacterial classes is higher in intervention arm compared to control arm. Diversity of skin bacterial classes is higher in intervention arm compared to control arm. Other community changes include changes in relative abundance, richness and in community composition. If community changes are found, the same difference is searched for in the comparison of surface soil microbiota of intervention versus standard daycare yards. Diversity is measured as Shannon diversity index, Multivariate Homogeneity of Group Dispersions and the number of taxa (richness).
Measured: 28 days
Skin bacterial community changes at order level
Order level diversity is higher in intervention arm than control arm (in standard daycares). Other community changes include changes in relative abundance, richness and in community composition. If community changes are found, the same difference is searched for in the comparison of surface soil microbiota of intervention versus standard daycare yards.
Measured: 28 days
Skin bacterial community changes at family level are higher in intervention than control arm
If differences are found, it will be checked if diversity of one or more skin bacterial families is related to soil bacterial diversity. Diversity is measured as Shannon diversity index, Multivariate Homogeneity of Group Dispersions and the number of taxa (richness).
Measured: 28 days
Skin bacterial community changes at genus level
Diversity of skin bacterial genera is related to arms, i.e. higher in intervention arm. If differences are found, it will be checked if these occur also in soil bacterial diversity. Diversity is measured as Shannon diversity index, Multivariate Homogeneity of Group Dispersions and the number of taxa (richness).
Measured: 28 days
Stool bacterial community changes at phylum level
Community composition of gut bacterial phyla are different between arms. Other changes include changes in relative abundance, richness and diversity.
Measured: 28 days
Stool bacterial community changes at class level
Community composition of gut bacterial classes are different between arms. Other changes include changes in relative abundance, richness and diversity.
Measured: 28 days
Stool bacterial community changes at order level
Community composition of gut bacterial orders are different between arms. Other changes include changes in relative abundance, richness and diversity.
Measured: 28 days
Stool bacterial community changes at family level
Community composition of gut bacterial families, particularly Ruminococcaceae, is different between arms. Ruminococcaceae contain taxa associated with the production of short chain fatty acids, such as butyrate. Other changes include changes in relative abundance, richness and diversity.
Measured: 28 days
Gut Faecalibacterium community changes
Community composition of gut Faecalibacterium is different between arms. Faecalibacterium has been associated with gut health and low incidence of certain immune mediated diseases.
Measured: 28 days
Associations between serum plasma TGF-beta and skin microbiota changes
change in the cytokine will be separately compared with changes in bacterial diversity on skin
Measured: 28 days
Associations between serum plasma IL-10 and skin Gammaproteobacterial microbiota changes
change in the cytokine will be separately compared with changes in Gammaproteobacterial diversity on skin
Measured: 28 days
Associations between serum plasma IL-17 and skin Gammaproteobacterial microbiota changes
change in the cytokine will be separately compared with changes in Gammaproteobacterial diversity on skin
Measured: 28 days
Interleukin-10 : interleukin-17A ratio in serum plasma
An increase IL-10: IL-17A ratio in each arm at the end of the 28 day intervention will be examined
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion30 Jun 2018
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ige Responsiveness, AtopicStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Tampere University of Technology
- Responsible party
- Principal investigator, Aki Sinkkonen, University of Helsinki
- Investigators
- Aki Sinkkonen, Docent, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733926
- Sponsor's protocol ID
- HelsinkiU1
- Acronym
- ADELEWP1t7
- Status last verified
- Jul 2019
- First submitted
- 23 Mar 2016
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available when the project has ended. Before it data will be available once the results have been published. Individual participants or families will not be recognizable in the public data set. If there is a danger that a person can be recognized, the data will not be made public. Finnish law and the decision of the ethical committee may limit public availability of data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADELE: Autoimmune Defense and Living Environment Acronym Description: Adele Comes From the Capitalized Words in the Following Words: Autoimmune DEfense and Living Environment
- ClinicalTrials.gov ID
- NCT02733926
- Acronym / sponsor ID
- ADELEWP1t7 / HelsinkiU1
- Conditions
- Ige Responsiveness, Atopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Tampere University, Tampere University of Technology
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- 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.
This study evaluates the effect of vegetation cover on certain Interleukin-10 and immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten that does not have forest floor and agricultural land in the backyards, or alternatively they will be in a kindergarten that does have forest floor and agricultural land in the backyards.
Detailed description
High vegetation cover is assumed to change immunoglobulinE (IgE) and interleukin-10 concentrations in blood serum. Children living in high-green kindergarten are compared with those kindergarten living utilizing backyards with a low-green cover.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| City kindergarten | No intervention | –Children living in a normal city kindergarten that hardly has vegetation in backyards |
| adding of vegetation into the backyards. | Experimental | Other: Adding of vegetation into the backyards of kindergartenChildren living in a normal city kindergarten that has plenty of vegetation in backyards. Intervention: adding of vegetation into the backyards. |
| Nature kindergarten | No intervention | –Children living in a city kindergarten where children go regularly into a natural forest |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children living in study kindergartens
Key exclusion criteria (8 listed)
- immune system deficiency, e.g. HIV-infection
- a drug decreasing immune system response, e.g. oral corticosteroid
- immune system disorder that affects immune response, e.g. rheumatoid
- colitis ulcerosa, Crohn disease, diabetes
- cancer
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 |
|---|---|---|
| Adding of vegetation into the backyards of kindergartenLiving plants are transferred into the backyards of kindergartens. This is assumed to affect the measured variables of children. | Other | adding of vegetation into the backyards. |
Primary outcome
Diversity of Gammaproteobacteria on skin.
Time frame: 28 days
Diversity of skin Gammaproteobacteria is higher in intervention arm compared to control arm and similar compared to nature-oriented arm after 28-day intervention. It will be measured at baseline and after 28-day intervention.
18 secondary outcomes
TGF-beta change in serum plasma
Time frame: 28 days
TGF-beta: IL-17A ratio in serum plasma
Time frame: 28 days
IL-10 change in serum plasma
Time frame: 28 days
IL-17A change in serum plasma
Time frame: 28 days
Skin bacterial community changes at phylum level
Time frame: 28 days
Skin bacterial community changes at class level
Time frame: 28 days
Skin bacterial community changes at order level
Time frame: 28 days
Skin bacterial community changes at family level are higher in intervention than control arm
Time frame: 28 days
Skin bacterial community changes at genus level
Time frame: 28 days
Stool bacterial community changes at phylum level
Time frame: 28 days
Stool bacterial community changes at class level
Time frame: 28 days
Stool bacterial community changes at order level
Time frame: 28 days
Stool bacterial community changes at family level
Time frame: 28 days
Gut Faecalibacterium community changes
Time frame: 28 days
Associations between serum plasma TGF-beta and skin microbiota changes
Time frame: 28 days
Associations between serum plasma IL-10 and skin Gammaproteobacterial microbiota changes
Time frame: 28 days
Associations between serum plasma IL-17 and skin Gammaproteobacterial microbiota changes
Time frame: 28 days
Interleukin-10 : interleukin-17A ratio in serum plasma
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: Yes. Data will be available when the project has ended. Before it data will be available once the results have been published. Individual participants or families will not be recognizable in the public data set. If there is a danger that a person can be recognized, the data will not be made public. Finnish law and the decision of the ethical committee may limit public availability of data.
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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. This study is not recruiting at the moment.
Aki Sinkkonen, Docent principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adding of vegetation into the backyards of kindergarten in people with Ige Responsiveness, Atopic, run by University of Helsinki at 1 site 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 8 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diversity of Gammaproteobacteria on skin. (time frame: 28 days). 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 17 Jul 2019.