Effect of Vegetation in Kindergartens on the Immune Response of Children (ADELEWP1t7)

July 16, 2019 updated by: Aki Sinkkonen, University of Helsinki

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Häme
      • Lahti, Häme, Finland, 15140
        • Helsinki University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: City kindergarten
Children living in a normal city kindergarten that hardly has vegetation in backyards
Experimental: adding of vegetation into the backyards.

Children living in a normal city kindergarten that has plenty of vegetation in backyards.

Intervention: adding of vegetation into the backyards.
Other: Adding of vegetation into the backyards of kindergarten
Living plants are transferred into the backyards of kindergartens. This is assumed to affect the measured variables of children.
No Intervention: Nature kindergarten
Children living in a city kindergarten where children go regularly into a natural forest

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TGF-beta change in serum plasma
Time Frame: 28 days
An increase in TGF-beta in intervention arm but not in control arm at the end of the 28 days intervention
28 days
TGF-beta: IL-17A ratio in serum plasma
Time Frame: 28 days
An increase in TGF-beta: IL17A ratio in intervention arm but not in control arm at the end of the 28 days intervention
28 days
IL-10 change in serum plasma
Time Frame: 28 days
An increase in IL-10 in intervention arm but not in control arm at the end of the 28 days intervention
28 days
IL-17A change in serum plasma
Time Frame: 28 days
A decrease in IL-17A in intervention arm but not in control arm at the end of the 28 days intervention
28 days
Skin bacterial community changes at phylum level
Time Frame: 28 days
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).
28 days
Skin bacterial community changes at class level
Time Frame: 28 days
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).
28 days
Skin bacterial community changes at order level
Time Frame: 28 days
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.
28 days
Skin bacterial community changes at family level are higher in intervention than control arm
Time Frame: 28 days
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).
28 days
Skin bacterial community changes at genus level
Time Frame: 28 days
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).
28 days
Stool bacterial community changes at phylum level
Time Frame: 28 days
Community composition of gut bacterial phyla are different between arms. Other changes include changes in relative abundance, richness and diversity.
28 days
Stool bacterial community changes at class level
Time Frame: 28 days
Community composition of gut bacterial classes are different between arms. Other changes include changes in relative abundance, richness and diversity.
28 days
Stool bacterial community changes at order level
Time Frame: 28 days
Community composition of gut bacterial orders are different between arms. Other changes include changes in relative abundance, richness and diversity.
28 days
Stool bacterial community changes at family level
Time Frame: 28 days
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.
28 days
Gut Faecalibacterium community changes
Time Frame: 28 days
Community composition of gut Faecalibacterium is different between arms. Faecalibacterium has been associated with gut health and low incidence of certain immune mediated diseases.
28 days
Associations between serum plasma TGF-beta and skin microbiota changes
Time Frame: 28 days
change in the cytokine will be separately compared with changes in bacterial diversity on skin
28 days
Associations between serum plasma IL-10 and skin Gammaproteobacterial microbiota changes
Time Frame: 28 days
change in the cytokine will be separately compared with changes in Gammaproteobacterial diversity on skin
28 days
Associations between serum plasma IL-17 and skin Gammaproteobacterial microbiota changes
Time Frame: 28 days
change in the cytokine will be separately compared with changes in Gammaproteobacterial diversity on skin
28 days
Interleukin-10 : interleukin-17A ratio in serum plasma
Time Frame: 28 days
An increase IL-10: IL-17A ratio in each arm at the end of the 28 day intervention will be examined
28 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Associations between IL-10 and stool commensal microbiota
Time Frame: 28 days
Associations between serum plasma cytokine IL-10 and gut microbiota changes are related to intervention. Bacterial communities are related to immune response in one or more arms.
28 days
Associations between IL-17 and stool commensal microbiota
Time Frame: 28 days
Associations between serum plasma IL-17 and gut microbiota changes are related to intervention. Bacterial communities are related to immune response in one or more arms.
28 days
Associations between TGF-beta and stool commensal microbiota
Time Frame: 28 days
Associations between serum plasma TGF-beta and gut microbiota changes are related to intervention. Bacterial communities are related to immune response in one or more arms.
28 days
Associations between IL-10: IL-17 ratio and stool commensal microbiota
Time Frame: 28 days
Associations between serum plasma IL-10: IL-17ratios and gut microbiota changes are related to intervention. Bacterial communities are related to immune response in one or more arms.
28 days
Associations between TGF-beta: IL-17 ratio and stool commensal microbiota
Time Frame: 28 days
Associations between serum plasma TGF-beta: IL-17 ratio and gut microbiota changes are related to intervention. Bacterial communities are related to immune response in one or more arms.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Helsinki

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tampere University
Tampere University of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aki Sinkkonen, Docent, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HelsinkiU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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