Atopic Disorders, Immune System Diseases
Conditions
Keywords
biodiversity intervention, sand box, guidance
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.
Interventions
OTHERBiodiversity powder
Biodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens.
OTHERPlacebo
Sand that looks like intervention sand but does not have high biodiversity
Sponsors
Tampere University
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
One arm received biodiversity sand and the other arm normal sand.
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin 10 level in blood | two weeks | The difference between day 0 and a follow up day in intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Finland
Outcome results
None listed