Effect of Vegetation in Kindergartens on the Immune Response of Children
ADELEWP1t7
ADELE: Autoimmune Defense and Living Environment Acronym Description: Adele Comes From the Capitalized Words in the Following Words: Autoimmune DEfense and Living Environment
1 other identifier
interventional
100
1 country
1
Brief 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 floor and agricultural land in the backyards.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 17, 2019
July 1, 2019
2.2 years
March 23, 2016
July 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
28 days
Secondary Outcomes (18)
TGF-beta change in serum plasma
28 days
TGF-beta: IL-17A ratio in serum plasma
28 days
IL-10 change in serum plasma
28 days
IL-17A change in serum plasma
28 days
Skin bacterial community changes at phylum level
28 days
- +13 more secondary outcomes
Other Outcomes (5)
Associations between IL-10 and stool commensal microbiota
28 days
Associations between IL-17 and stool commensal microbiota
28 days
Associations between TGF-beta and stool commensal microbiota
28 days
- +2 more other outcomes
Study Arms (3)
City kindergarten
NO INTERVENTIONChildren living in a normal city kindergarten that hardly has vegetation in backyards
adding of vegetation into the backyards.
EXPERIMENTALChildren living in a normal city kindergarten that has plenty of vegetation in backyards. Intervention: adding of vegetation into the backyards.
Nature kindergarten
NO INTERVENTIONChildren living in a city kindergarten where children go regularly into a natural forest
Interventions
Living plants are transferred into the backyards of kindergartens. This is assumed to affect the measured variables of children.
Eligibility Criteria
You may qualify if:
- \- children living in study kindergartens
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Helsinkilead
- Tampere Universitycollaborator
- Tampere University of Technologycollaborator
Study Sites (1)
Helsinki University
Lahti, Kanta-Häme, 15140, Finland
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Aki Sinkkonen, Docent
University of Helsinki
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University researcher, docent
Study Record Dates
First Submitted
March 23, 2016
First Posted
April 12, 2016
Study Start
April 1, 2016
Primary Completion
June 30, 2018
Study Completion
December 1, 2019
Last Updated
July 17, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
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.