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Status unknownNCT04189978Updated Jul 19, 2022

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

An observational study in Allergic Disorder, sponsored by Brugmann University Hospital. Status unknown at 1 site in Belgium. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Brugmann University Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Ages
12 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Allergic Disorder

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03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's planned enrollment of 320 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Brugmann University Hospital is the lead sponsor of 116 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testClinical 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.

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What researchers measure

Primary outcomes

  1. Prevalence of positivity of allergic skin tests

    Prevalence of positivity of allergic skin tests

    Time frame: 1 year

  2. Prevalence of positivity of ImmunoCAP tests

    Prevalence of positivity of ImmunoCAP tests

    Time frame: 1 year

Secondary outcomes

  1. Prevalence of clinical manifestations of allergy

    Prevalence of clinical manifestations of allergy (atopic eczema, food allergy, asthma and rhinitis).

    Time frame: 1 year

  2. Prevalence of confirmed asthma

    Prevalence of confirmed asthma (clinical manifestations, spirometry and FeNO)

    Time frame: 1 year

  3. Spirometry results

    Spirometry results

    Time frame: 1 year

  4. Exhaled fraction of NO (FeNO) results

    Exhaled fraction of NO (FeNO) results

    Time frame: 1 year

  5. Eosinophilia count

    Eosinophilia count

    Time frame: 1 year

  6. Socio-cultural status

    Socio-cultural status

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • CHU Brugmann
    Brussel, 1020, Belgium
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04189978
Lead sponsor
Brugmann University Hospital
Responsible party
Olivier Michel (Head of immuno-allergology departement, Brugmann University Hospital) — Principal investigator
First posted
Dec 9, 2019
Start date
Nov 12, 2019
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jul 19, 2022

Study contacts

Olivier Michel, MD
Contact
Olivier.MICHEL@chu-brugmann.be
3224773664
Olivier Michel, MD
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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