Biodiversity Intervention and Atopic Sensitization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Atopy Allergy Allergic Rhinitis Allergic Sensitisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study consists of two arms, the intervention arm and the placebo arm. Children are randomized into the arms.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind randomized trial

Study Groups

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Placebo

The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.

Group Type PLACEBO_COMPARATOR

Nature-based materials

Intervention Type COMBINATION_PRODUCT

In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.

intervention arm

The children will receive and they are exposed daily to materials of high microbiological biodiversity.

Group Type EXPERIMENTAL

Nature-based materials

Intervention Type COMBINATION_PRODUCT

In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes