Effect of Modified Playground Environment on Health, Particularly Immune System

NCT03997175 | Completed

• 1 other identifier: HelsinkiUIG1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Disorders; Immune System Diseases

Keywords

biodiversity intervention; sand box; guidance

Outcome Measures

Primary Outcomes (1)

• Change in Interleukin 10 level in blood

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

  two weeks

Secondary Outcomes (5)

• changes in microbiota

  two weeks

• changes in interleukin 17 levels

  two weeks

• changes in tgf-beta levels

  two weeks

• ratio il-10 / il-17

  two weeks

• long-term changes in microbiota

  four weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The children were in daily contact with biodiversity sand 5 days a week for two weeks.

Other: Biodiversity powder

Placebo

PLACEBO COMPARATOR

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

Interventions

Biodiversity powder OTHER

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

Also known as: Biodiversity sand, Biodiversity intervention

Intervention

Placebo OTHER

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

Also known as: Placebo sand

Placebo

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy
• born in Finland
• spends daily (5 d a week) several hours in one of the daycares in which the trial was performed

You may not qualify if:

• medication affecting immune system function
• medication affecting microbiota
• cancer
• immune deficiency
• living on a farm
• not born in Finland

Sponsors & Collaborators

• University of Helsinki: lead
• Tampere University: collaborator

Study Sites (1)

Helsinki University

Lahti, Kanta-Häme, 15140, Finland

Location

MeSH Terms

Conditions

Immune System Diseases

Study Officials

• Aki Sinkkonen, ph d

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants nor their parents did not know the arm. Care providers did not know the group as they did not know the content of the sand box. Investigators and field assistants knew the content in each sand box but they did not know the coding of the arms when they analyzed the differences in cytokine levels. Outcomes assessors i.e. nurses who took blood samples did not know the arms nor the contents of the sand boxes.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Researcher

Model Details: One arm received biodiversity sand and the other arm normal sand.

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 25, 2019
• Study Start: April 15, 2018
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

FI (1)