Biodiversity Intervention and Atopic Sensitization

Not Applicable

Not yet recruiting

• Conditions: Atopy; Allergic Sensitisation; Allergy; Allergic Rhinitis
• Interventions: Combination Product: Nature-based materials

• Registration Number: NCT03872219
• Lead Sponsor: University of Helsinki

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Study First Posted: 2019-03-13
• Last Update Posted: 2019-03-13
• Study Start: 2019-03-25
• Primary Completion: 2023-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention arm	Nature-based materials	The children will receive and they are exposed daily to materials of high microbiological biodiversity.
Placebo	Nature-based materials	The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.

Primary Outcome Measures

Name	Time	Method
IgE sensitization	2-3 years	IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.

Secondary Outcome Measures

Name	Time	Method
Allergic symptoms	2-3 years	All possible allergic symptomes, including atopy, will be estimated