An interventional study of Nature-based materials in Atopy, Allergy and Allergic Rhinitis, sponsored by University of Helsinki. Not yet recruiting. Open to participants aged Up to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by University of Helsinki · Not applicable, Interventional, and Prevention
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.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's planned enrollment of 350 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.
Combination Product: Nature-based materials
The children will receive and they are exposed daily to materials of high microbiological biodiversity.
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.
IgE sensitization
IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.
Time frame: 2-3 years
Allergic symptoms
All possible allergic symptomes, including atopy, will be estimated
Time frame: 2-3 years
IL-10: IL-17 ratio
Time frame: 2-3 years
TGF-beta level
Time frame: 2-3 years
IL-10 levels
Time frame: 2-3 years
No study locations are listed for this record.
Plan to share: No — We will share it according to Finnish legislation and ethical committee permission. The permission restrict sharing tightly.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Helsinki