Effect of Modified Playground Environment on Health, Particularly Immune System

Immune System Diseases Clinical Trial

— ImmunoG1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997175
• Other study ID #: HelsinkiUIG1
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: June 2019
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Disorders
• Immune System Diseases

Intervention

Other:
• Biodiversity powder
Biodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens.
• Placebo
Sand that looks like intervention sand but does not have high biodiversity

Locations

Country	Name	City	State
Finland	Helsinki University	Lahti	Häme

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Interleukin 10 level in blood	The difference between day 0 and a follow up day in intervention	two weeks
Secondary	changes in microbiota	all potential changes in bacterial profile are measured on skin and stool samples	two weeks
Secondary	changes in interleukin 17 levels	all measured changes in interleukin 17 levels	two weeks
Secondary	changes in tgf-beta levels	change in tgf-beta levels	two weeks
Secondary	ratio il-10 / il-17	potential changes in the ratio of these two citokines	two weeks
Secondary	long-term changes in microbiota	potential changes that last for four weeks	four weeks