Allergic DisorderNCT04189978
Impact of Microbial Exposure of the Habitat at the Time of Birth on the Development of Allergic Diseases.
An observational study of Allergic Disorder, run by Brugmann University Hospital at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Disorder
- What is being tested?
- Clinical evaluation
- How many people
- 320 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Olivier Michel, MD, Olivier.MICHEL@chu-brugmann.be
Olivier Michel, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- Allergic Disorder
- Being tested
- Clinical evaluation
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positivity of allergic skin tests
Prevalence of positivity of allergic skin tests
Measured: 1 year
Prevalence of positivity of ImmunoCAP tests
Prevalence of positivity of ImmunoCAP tests
Measured: 1 year
Secondary outcomes (6)
Prevalence of clinical manifestations of allergy
Prevalence of clinical manifestations of allergy (atopic eczema, food allergy, asthma and rhinitis).
Measured: 1 year
Prevalence of confirmed asthma
Prevalence of confirmed asthma (clinical manifestations, spirometry and FeNO)
Measured: 1 year
Spirometry results
Spirometry results
Measured: 1 year
Exhaled fraction of NO (FeNO) results
Exhaled fraction of NO (FeNO) results
Measured: 1 year
Eosinophilia count
Eosinophilia count
Measured: 1 year
Socio-cultural status
Socio-cultural status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start12 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Michel, Brugmann University Hospital
- Investigators
- Olivier Michel, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189978
- Sponsor's protocol ID
- CHUB-ENVIBRU
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Microbial Exposure of the Habitat at the Time of Birth on the Development of Allergic Diseases.
- ClinicalTrials.gov ID
- NCT04189978
- Acronym / sponsor ID
- CHUB-ENVIBRU
- Conditions
- Allergic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2001-2002 study participants | – | Diagnostic Test: Clinical evaluationChildren who participated in the study conducted in 2001-2002, their parents and the siblings who were exposed to the same environment at this period. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluationThe 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. | Diagnostic test | 2001-2002 study participants |
Primary outcome
Prevalence of positivity of allergic skin tests
Time frame: 1 year
Prevalence of positivity of allergic skin tests
Prevalence of positivity of ImmunoCAP tests
Time frame: 1 year
Prevalence of positivity of ImmunoCAP tests
6 secondary outcomes
Prevalence of clinical manifestations of allergy
Time frame: 1 year
Prevalence of confirmed asthma
Time frame: 1 year
Spirometry results
Time frame: 1 year
Exhaled fraction of NO (FeNO) results
Time frame: 1 year
Eosinophilia count
Time frame: 1 year
Socio-cultural status
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Allergic Disorder
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Michel, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Disorder, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Michel, MD (3224773664, Olivier.MICHEL@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of positivity of allergic skin tests (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.