Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Allergic Rhinitis
  • Allergic Sensitisation
  • Allergy
  • Atopy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blind randomized trialPrimary Purpose: Prevention

Participation Requirements

Age
Younger than 1 years
Gender
Both males and females

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 sen...

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.

Tracking Information

NCT #
NCT03872219
Collaborators
  • Tampere University
  • Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)
  • Business Finland (National Innovation Agency)
Investigators
Not Provided