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

University of Helsinki

Status: Completed

Conditions: Atopic Disorders; Immune System Diseases

Treatments: Other: Placebo; Other: Biodiversity powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03997175

HelsinkiUIG1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

25 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Other: Biodiversity powder

Placebo

Placebo Comparator group

Description:

Children were in contact with normal but colored sand that looked as it were the biodiversity sand. All the other details were as above.

Treatment:

Other: Placebo