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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Disorder
• Intervention / Treatment: Diagnostic test: Clinical evaluation

• Study Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

• Study Contact: Name: Olivier Michel, MD; Phone Number: 3224773664; Email: Olivier.MICHEL@chu-brugmann.be

Study Locations

• Belgium
  • Brussel, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Contact: Olivier Michel, MD; Email: Olivier.MICHEL@chu-brugmann.be
    • Principal Investigator: Olivier Michel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2001-2002 study participants; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of positivity of allergic skin tests	Prevalence of positivity of allergic skin tests	1 year
Prevalence of positivity of ImmunoCAP tests	Prevalence of positivity of ImmunoCAP tests	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Olivier Michel, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: CHUB-ENVIBRU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No