- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04189978
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:
- A protective effect of airborne dust endotoxins on the risk of developing atopic dermatitis in children at 6 and 12 months of life,
- 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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Olivier Michel, MD
- Phone Number: 3224773664
- Email: Olivier.MICHEL@chu-brugmann.be
Study Locations
-
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
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.
|
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
Time Frame: 1 year
|
Prevalence of positivity of allergic skin tests
|
1 year
|
Prevalence of positivity of ImmunoCAP tests
Time Frame: 1 year
|
Prevalence of positivity of ImmunoCAP tests
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of clinical manifestations of allergy
Time Frame: 1 year
|
Prevalence of clinical manifestations of allergy (atopic eczema, food allergy, asthma and rhinitis).
|
1 year
|
Prevalence of confirmed asthma
Time Frame: 1 year
|
Prevalence of confirmed asthma (clinical manifestations, spirometry and FeNO)
|
1 year
|
Spirometry results
Time Frame: 1 year
|
Spirometry results
|
1 year
|
Exhaled fraction of NO (FeNO) results
Time Frame: 1 year
|
Exhaled fraction of NO (FeNO) results
|
1 year
|
Eosinophilia count
Time Frame: 1 year
|
Eosinophilia count
|
1 year
|
Socio-cultural status
Time Frame: 1 year
|
Socio-cultural status
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier Michel, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-ENVIBRU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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