Asthma in ChildrenMicrobiosthmeNCT06044051
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
A study testing Blood sample, Expectoration and Nasopharyngeal swab in people with Asthma in Children and Asthma, run by University Hospital, Rouen at 1 site in France.
Trial summary
Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Asthma in Children, Asthma
- What is being tested?
- Blood sample, Expectoration and Nasopharyngeal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2023to 26 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants less than 24 months old
- Follow-up by a pneumo-pediatrician for severe asthma in infants
- Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)
- Parent informed of the research and having signed consent
Who cannot join
- Prematurity <32 WA
- Congenital heart disease with significant left to right shunt
- Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)
- Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)
- Refusal of bronchial fibroscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rouen University Hospital
Rouen
Hortense PETAT
About this study
Official title: Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons
Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.
Exploring and understanding these data is to improve patient care and discover new therapeutic targets.
The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.
- Conditions
- Asthma in Children, Asthma
- Being tested
- Blood sample, Expectoration, Nasopharyngeal swab
- Keywords
- microbiosme, Asthma in infant
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
An additionnal volume of blood will be collected at inclusion and at each follow-up visit
ExpectorationOther
Expectoration will be collected at inclusion and at each follow-up visit
Nasopharyngeal swabOther
A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All patients included will be followed for 1 year, every 3 months Receives: Other: Blood sample; Other: Expectoration; Other: Nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of microbiomes from bronchoalveolar fluids
analysis of bronchoalveolar fluids - NGS sequencing
Measured: Inclusion
description of microbiomes from nasopharyngeal samples
analysis of nasopharyngeal samples- NGS sequencing
Measured: Inclusion
description of microbiomes from sputum samples
analysis of sputum samples- NGS sequencing
Measured: Inclusion
description of microbiomes from bronchoalveolar fluids
analysis of bronchoalveolar fluids- NGS sequencing
Measured: at 3 months
description of microbiomes from nasopharyngeal samples
analysis of nasopharyngeal samples- NGS sequencing
Measured: at 3 months
description of microbiomes from sputum samples
analysis of sputum samples- NGS sequencing
Measured: at 3 months
description of microbiomes from bronchoalveolar fluids
analysis of bronchoalveolar fluids- NGS sequencing
Measured: at 6 months
description of microbiomes from nasopharyngeal samples
analysis of nasopharyngeal samples- NGS sequencing
Measured: at 6 months
description of microbiomes from sputum samples
analysis of sputum samples- NGS sequencing
Measured: at 6 months
description of microbiomes from bronchoalveolar fluids
analysis of bronchoalveolar fluids - NGS sequencing
Measured: at 9 months
description of microbiomes from nasopharyngeal samples
analysis of nasopharyngeal samples- NGS sequencing
Measured: at 9 months
description of microbiomes from sputum samples
analysis of sputum samples- NGS sequencing
Measured: at 9 months
description of microbiomes from bronchoalveolar fluids
analysis of bronchoalveolar fluids- NGS sequencing
Measured: at 12 months
description of microbiomes from nasopharyngeal samples
analysis of nasopharyngeal samples- NGS sequencing
Measured: at 12 months
Description of microbiomes from sputum samples
analysis of sputum samples- NGS sequencing
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start26 Sep 2023
- Primary completion26 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PETAT Hortense, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044051
- Sponsor's protocol ID
- 2023/0091/HP
- Acronym
- Microbiosthme
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Petat H, Hassel C, Michel A, Charbonnier C, Plantier JC, Marguet C. Microbiosthma: a prospective study following respiratory microbiota in young children with severe preschool wheezing to better understand their respiratory future. BMC Pulm Med. 2025 Jul 16;25(1):342. doi: 10.1186/s12890-025-03812-9.
PubMed 40670979
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons
- ClinicalTrials.gov ID
- NCT06044051
- Acronym / sponsor ID
- Microbiosthme / 2023/0091/HP
- Conditions
- Asthma in Children, Asthma
- Keywords
- microbiosme, Asthma in infant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 26 Sep 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.
Exploring and understanding these data is to improve patient care and discover new therapeutic targets.
The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Other: Blood sample, Other: Expectoration, Other: Nasopharyngeal swabAll patients included will be followed for 1 year, every 3 months |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants less than 24 months old
- Follow-up by a pneumo-pediatrician for severe asthma in infants
- Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)
- Parent informed of the research and having signed consent
Key exclusion criteria (5 listed)
- Prematurity <32 WA
- Congenital heart disease with significant left to right shunt
- Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)
- Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)
- Refusal of bronchial fibroscopy
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 |
|---|---|---|
| Blood sampleAn additionnal volume of blood will be collected at inclusion and at each follow-up visit | Other | All patients |
| ExpectorationExpectoration will be collected at inclusion and at each follow-up visit | Other | All patients |
| Nasopharyngeal swabA nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum | Other | All patients |
Primary outcome
description of microbiomes from bronchoalveolar fluids
Time frame: Inclusion
analysis of bronchoalveolar fluids - NGS sequencing
description of microbiomes from nasopharyngeal samples
Time frame: Inclusion
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples
Time frame: Inclusion
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
Time frame: at 3 months
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from nasopharyngeal samples
Time frame: at 3 months
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples
Time frame: at 3 months
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
Time frame: at 6 months
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from nasopharyngeal samples
Time frame: at 6 months
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples
Time frame: at 6 months
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
Time frame: at 9 months
analysis of bronchoalveolar fluids - NGS sequencing
description of microbiomes from nasopharyngeal samples
Time frame: at 9 months
analysis of nasopharyngeal samples- NGS sequencing
description of microbiomes from sputum samples
Time frame: at 9 months
analysis of sputum samples- NGS sequencing
description of microbiomes from bronchoalveolar fluids
Time frame: at 12 months
analysis of bronchoalveolar fluids- NGS sequencing
description of microbiomes from nasopharyngeal samples
Time frame: at 12 months
analysis of nasopharyngeal samples- NGS sequencing
Description of microbiomes from sputum samples
Time frame: at 12 months
analysis of sputum samples- NGS sequencing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 40670979Petat H, Hassel C, Michel A, Charbonnier C, Plantier JC, Marguet C. Microbiosthma: a prospective study following respiratory microbiota in young children with severe preschool wheezing to better understand their respiratory future. BMC Pulm Med. 2025 Jul 16;25(1):342. doi: 10.1186/s12890-025-03812-9.
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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.
PETAT Hortense principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Expectoration and Nasopharyngeal swab in people with Asthma in Children and Asthma, run by University Hospital, Rouen at 1 site in France.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Mallet (02 32 88 82 65 ext. +33, secretariat.DRC@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of microbiomes from bronchoalveolar fluids (time frame: Inclusion). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06044051, which also lists 1 linked publication.
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 17 Feb 2026.