Clinical trial NCT02733926: Effect of Vegetation in Kindergartens on the Immune Response of Children
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ige Responsiveness, Atopic
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Tampere University of Technology
First posted: 2016-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

- children living in study kindergartens

Exclusion Criteria:

* 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

Primary outcomes:
measure: Diversity of Gammaproteobacteria on skin.
timeFrame: 28 days
Secondary outcomes:
measure: TGF-beta change in serum plasma
timeFrame: 28 days
measure: TGF-beta: IL-17A ratio in serum plasma
timeFrame: 28 days
measure: IL-10 change in serum plasma
timeFrame: 28 days
measure: IL-17A change in serum plasma
timeFrame: 28 days
measure: Skin bacterial community changes at phylum level
timeFrame: 28 days
measure: Skin bacterial community changes at class level
timeFrame: 28 days
measure: Skin bacterial community changes at order level
timeFrame: 28 days
measure: Skin bacterial community changes at family level are higher in intervention than control arm
timeFrame: 28 days
measure: Skin bacterial community changes at genus level
timeFrame: 28 days
measure: Stool bacterial community changes at phylum level
timeFrame: 28 days
measure: Stool bacterial community changes at class level
timeFrame: 28 days
measure: Stool bacterial community changes at order level
timeFrame: 28 days
measure: Stool bacterial community changes at family level
timeFrame: 28 days
measure: Gut Faecalibacterium community changes
timeFrame: 28 days
measure: Associations between serum plasma TGF-beta and skin microbiota changes
timeFrame: 28 days
measure: Associations between serum plasma IL-10 and skin Gammaproteobacterial microbiota changes
timeFrame: 28 days
measure: Associations between serum plasma IL-17 and skin Gammaproteobacterial microbiota changes
timeFrame: 28 days
measure: Interleukin-10 : interleukin-17A ratio in serum plasma
timeFrame: 28 days
Other outcomes:
measure: Associations between IL-10 and stool commensal microbiota
timeFrame: 28 days
measure: Associations between IL-17 and stool commensal microbiota
timeFrame: 28 days
measure: Associations between TGF-beta and stool commensal microbiota
timeFrame: 28 days
measure: Associations between IL-10: IL-17 ratio and stool commensal microbiota
timeFrame: 28 days
measure: Associations between TGF-beta: IL-17 ratio and stool commensal microbiota
timeFrame: 28 days
Locations:
city: Lahti
country: Finland
facility: Helsinki University
state: Häme
Study officials:
affiliation: University of Helsinki
name: Aki Sinkkonen, Docent
role: PRINCIPAL_INVESTIGATOR
References: