Status:
UNKNOWN
Biodiversity Intervention and Atopic Sensitization
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Tampere University
Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)
Conditions:
Atopy
Allergy
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief 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 t...
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 ...
Eligibility Criteria
Inclusion
- both parents have atopy
- newborn
Exclusion
- severe disease, particularly immune system deficiency or down syndrome or cancer
- medication affecting immune system
- birth before week 35 in pregnancy
- being a twin
- only one of the parents have atopy
- none of the parents have atopy
- children have passed the age of two months
- immune system disorder such as rheumatoid disease, colitis ulcerosa, Crohn disease, diabetes or genetic risk to type 1 diabetes
- no participation in national vaccination programme
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03872219
Start Date
March 25 2019
End Date
December 31 2025
Last Update
March 13 2019
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