Biodiversity Intervention and Atopic Sensitization

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atopy, Allergy, Allergic Rhinitis, Allergic Sensitisation

Intervention / Treatment
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* Combination Product: Nature-based materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.<br>|
| Experimental: intervention arm<br>The children will receive and they are exposed daily to materials of high microbiological biodiversity. | Combination Product: Nature-based materials<br>* In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgE sensitization | IgE sentitization is expected to be lower in the intervention arm than in the placebo arm. | 2-3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic symptoms | All possible allergic symptomes, including atopy, will be estimated | 2-3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biodiversity intervention, IgE, atopy