Impact of Microbial Exposure of the Habitat at the Time of Birth on the Development of Allergic Diseases.

• Conditions: Allergic Disorder
• Interventions: Diagnostic Test: Clinical evaluation

• Registration Number: NCT04189978
• Lead Sponsor: Brugmann University Hospital

Brief Summary

In 2001-2002, a longitudinal study on the risk of atopic sensitization in children was conducted by the Pneumo-Allergology and Pediatrics departments of the CHU Saint-Pierre Hospital and at the Neonatology Department of the Queen Fabiola Children's University Hospital (HUDERF). The aim of the study was to study bacteria and endotoxins in airborne dust in Brussels homes in order to evaluate their impact on the development of allergic diseases in newborns.

Between December 2000 and August 2002, 114 children (67 from HUDERF and 47 from CHU St-Pierre) were included in the study. These were eutrophic children without acquired pathology or known genetics.

Simultaneously a microbial habitat assessment was performed based on a detailed description and on endotoxin assays in the airborne and deposited dust (mainly mattress).These data can be used to define habitats with high or low contamination.Samples for microbial analyzes (Gram positive and negative and mold) were also carried out.

Preliminary results suggested:

1. A protective effect of airborne dust endotoxins on the risk of developing atopic dermatitis in children at 6 and 12 months of life,

2. An effect of endotoxins promoting the occurrence of wheezing in children after 6 months.

In this current, new study, the investigators will recontact the children who were included in the 2003 study. The goal is to evaluate them clinically and allergically and associate the risk of sensitization / allergic diseases with the microbial exposure of the habitat, measured during the neonatal period.

Siblings and parents who were exposed during the same period will also be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-12
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Children who participated in the study conducted in 2001-2002, their parents and the siblings who were exposed to the same environment at this period.

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2001-2002 study participants	Clinical evaluation	Children who participated in the study conducted in 2001-2002, their parents and the siblings who were exposed to the same environment at this period.

Primary Outcome Measures

Name	Time	Method
Prevalence of positivity of allergic skin tests	1 year	Prevalence of positivity of allergic skin tests
Prevalence of positivity of ImmunoCAP tests	1 year	Prevalence of positivity of ImmunoCAP tests

Secondary Outcome Measures

Name	Time	Method
Eosinophilia count	1 year	Eosinophilia count
Prevalence of clinical manifestations of allergy	1 year	Prevalence of clinical manifestations of allergy (atopic eczema, food allergy, asthma and rhinitis).
Prevalence of confirmed asthma	1 year	Prevalence of confirmed asthma (clinical manifestations, spirometry and FeNO)
Spirometry results	1 year	Spirometry results
Exhaled fraction of NO (FeNO) results	1 year	Exhaled fraction of NO (FeNO) results
Socio-cultural status	1 year	Socio-cultural status

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussel, Belgium