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

NCT04189978 | Unknown

• 1 other identifier: CHUB-ENVIBRU
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Prevalence of clinical manifestations of allergy

  1 year

• Prevalence of confirmed asthma

  1 year

• Spirometry results

  1 year

• Exhaled fraction of NO (FeNO) results

  1 year

• Eosinophilia count

  1 year

Study Arms (1)

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

Interventions

Clinical evaluation DIAGNOSTIC_TEST

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.

2001-2002 study participants

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Olivier Michel, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Michel, MD

CONTACT

3224773664; Olivier.MICHEL@chu-brugmann.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of immuno-allergology departement

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: November 12, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)