Effect of Modified Playground Environment on Health, Particularly Immune System

Study Overview
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Brief Summary
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Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed.

Detailed Description
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Children of age 3-5 were randomly divided into two groups (arms). One received guidance and biodiverse material for 20 minutes each day for two weeks. The other received the a similar material and guidance but the microbial community in the material was poor in diversity. Bacterial community changes and immune system markers were analyzed and compared between the two arms. Potential changes in Interleukin 10 was the primary outcome.

Official Title
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ImmunoGarden - Effect of Modified Playground Environment on Health, Particularly Immune System

Conditions
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Atopic Disorders, Immune System Diseases

Intervention / Treatment
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* Other: Biodiversity powder
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy born in Finland spends daily (5 d a week) several hours in one of the daycares in which the trial was performed Exclusion Criteria: medication affecting immune system function medication affecting microbiota cancer immune deficiency living on a farm not born in Finland

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm received biodiversity sand and the other arm normal sand.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The children were in daily contact with biodiversity sand 5 days a week for two weeks. | Other: Biodiversity powder<br>* Biodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens.<br>* Other names: Biodiversity intervention;|
| Placebo Comparator: Placebo<br>Children were in contact with normal but colored sand that looked as it were the biodiversity sand. All the other details were as above. | Other: Placebo<br>* Sand that looks like intervention sand but does not have high biodiversity<br>* Other names: Placebo sand;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Interleukin 10 level in blood | The difference between day 0 and a follow up day in intervention | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in microbiota | all potential changes in bacterial profile are measured on skin and stool samples | two weeks | 
| changes in interleukin 17 levels | all measured changes in interleukin 17 levels | two weeks | 
| changes in tgf-beta levels | change in tgf-beta levels | two weeks | 
| ratio il-10 / il-17 | potential changes in the ratio of these two citokines | two weeks | 
| long-term changes in microbiota | potential changes that last for four weeks | four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biodiversity intervention, sand box, guidance