Effect of Modified Playground Environment on Health, Particularly Immune System

Not Applicable

Completed

• Conditions: Atopic Disorders; Immune System Diseases
• Interventions: Other: Placebo; Other: Biodiversity powder

• Registration Number: NCT03997175
• Lead Sponsor: University of Helsinki

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-04-15
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-23
• Study First Submitted QC: 2019-06-23
• Last Update Submitted: 2019-06-23
• Study First Posted: 2019-06-25
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Children were in contact with normal but colored sand that looked as it were the biodiversity sand. All the other details were as above.
Intervention	Biodiversity powder	The children were in daily contact with biodiversity sand 5 days a week for two weeks.

Primary Outcome Measures

Name	Time	Method
Change in Interleukin 10 level in blood	two weeks	The difference between day 0 and a follow up day in intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Helsinki University; 🇫🇮 Lahti, Häme, Finland