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

Allergic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04189978
• Other study ID #: CHUB-ENVIBRU
• Status: Recruiting
• Start date: November 12, 2019
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: Olivier Michel, MD
• Phone: 3224773664
• Email: Olivier.MICHEL[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Disorder
• Hypersensitivity

Intervention

Diagnostic Test:
• Clinical evaluation
The assessment is based on a comprehensive questionnaire, a simple clinical examination, an spirometry test, allergic skin tests, measurement of the exhaled fraction of NO (FeNO) and blood serum analysis.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of positivity of allergic skin tests	Prevalence of positivity of allergic skin tests	1 year
Primary	Prevalence of positivity of ImmunoCAP tests	Prevalence of positivity of ImmunoCAP tests	1 year
Secondary	Prevalence of clinical manifestations of allergy	Prevalence of clinical manifestations of allergy (atopic eczema, food allergy, asthma and rhinitis).	1 year
Secondary	Prevalence of confirmed asthma	Prevalence of confirmed asthma (clinical manifestations, spirometry and FeNO)	1 year
Secondary	Spirometry results	Spirometry results	1 year
Secondary	Exhaled fraction of NO (FeNO) results	Exhaled fraction of NO (FeNO) results	1 year
Secondary	Eosinophilia count	Eosinophilia count	1 year
Secondary	Socio-cultural status	Socio-cultural status	1 year