NCT03872219

Biodiversity Intervention and Atopic Sensitization

The Effect of Plant and Soil-based Material on the Incidence of Atopic Sensitization

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Accepted

Summary

Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.

Detailed description

Newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. The proof of concept trial will be double blind. Intervention will start at the age of 2 months and it will end when children become 12 months old. Children will be randomized to the two arms. IgE sensitization is the primary outcome at the age of two and three years.

Conditions

• Atopy
• Allergy
• Allergic Rhinitis
• Allergic Sensitisation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Nature-based materials	In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.

Timeline

• Start date: 2019-03-25
• Primary completion: 2023-08-31
• Completion: 2025-12-31
• First posted: 2019-03-13
• Last updated: 2019-03-13