Effect of Modified Playground Environment on Health, Particularly Immune System (ImmunoG1)

ImmunoGarden - 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.

Study Overview

• Status: Completed
• Conditions: Immune System Diseases; Atopic Disorders
• Intervention / Treatment: Other: Biodiversity powder; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The children were in daily contact with biodiversity sand 5 days a week for two weeks.	Other: Biodiversity powder; 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 Comparator: 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.	Other: Placebo; Sand that looks like intervention sand but does not have high biodiversity; Other Names: Placebo sand

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Tampere University
• Investigators: Principal Investigator: Aki Sinkkonen, ph d, University of Helsinki

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: June 23, 2019
• First Submitted That Met QC Criteria: June 23, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 23, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: guidance; biodiversity intervention; sand box
• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: HelsinkiUIG1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The local ethical committee and the law in Finland retricts the sharing of information that could lead to distinguishing a study participant. Microbial information is considered to faciliation the identification of study participants. Microbial information will be partly shared to public databases (sequences).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No