Allergic Rhinitis, Allergic Sensitisation, Allergy, Atopy
Conditions
Keywords
biodiversity intervention, IgE, atopy
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 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.
Interventions
COMBINATION_PRODUCTNature-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.
Sponsors
Tampere University
Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)
Business Finland (National Innovation Agency)
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind randomized trial
Intervention model description
The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* both parents have atopy * newborn
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgE sensitization | 2-3 years | IgE sentitization is expected to be lower in the intervention arm than in the placebo arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allergic symptoms | 2-3 years | All possible allergic symptomes, including atopy, will be estimated |
Other
| Measure | Time frame |
|---|---|
| IL-10: IL-17 ratio | 2-3 years |
| TGF-beta level | 2-3 years |
| IL-10 levels | 2-3 years |
Contacts
Primary ContactAki Sinkkonen
Backup ContactRiikka Puhakka
Outcome results
None listed