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Completed

NCT Number: NCT03997175

Effect of Modified Playground Environment on Health, Particularly Immune System

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.

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Key information

Conditions

Atopic Disorders Immune System Diseases

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University

Lahti, Kanta-Häme, 15140, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biodiversity powder

Other

Biodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens.

Other names: Biodiversity sand, Biodiversity intervention

Placebo

Other

Sand that looks like intervention sand but does not have high biodiversity

Other names: Placebo sand

Primary outcomes

  1. Change in Interleukin 10 level in blood

    Time frame: two weeks

    The difference between day 0 and a follow up day in intervention

Secondary outcomes

  1. changes in microbiota

    Time frame: two weeks

    all potential changes in bacterial profile are measured on skin and stool samples

  2. changes in interleukin 17 levels

    Time frame: two weeks

    all measured changes in interleukin 17 levels

  3. changes in tgf-beta levels

    Time frame: two weeks

    change in tgf-beta levels

  4. ratio il-10 / il-17

    Time frame: two weeks

    potential changes in the ratio of these two citokines

  5. long-term changes in microbiota

    Time frame: four weeks

    potential changes that last for four weeks

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Tampere University

Registry information

Official study title

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

Acronym: ImmunoG1

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2019
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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