BronchiolitisBRONCHOBIOTENCT06161285
Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
An observational study of Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the… Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Sampling
- How many people
- 120 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Dec 2024to Apr 2026
- Phase
- Observational
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Bronchiolitis in patient under 12 months old
Who may be able to join
- Infants <12 months
- With bronchiolitis during RSV epidemic season
- No chronic illness
- No bronchiolitis medical history
- Signed consent from parents or legal guardians
Who cannot join
- Chronic respiratory illness
- Medical history of bronchiolitis or newborn asthma
- Treatment with immunosuppressants
- Patient with no social security affiliation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
APHP, Antoine Béclère Hospital
Clamart, 92140
Etienne BIZOT, Doctor, 33145374618, etienne.bizot@aphp.fr
- Recruiting
AP-HP,Raymond Poincaré Hospital
Garches, 92380
Justine ZINI, Doctor, 33147107880, justine.zini@aphp.fr
- Recruiting
Réanimation médico-chirurgicale Necker
Paris, 750
Charlotte Collignon, Dr, 95890, charlotte.collignon@aphp.fr
About this study
Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.
- Conditions
- Bronchiolitis
- Being tested
- Sampling
- Keywords
- Newborns, Dysbiosis, respiratory syncytial virus (RSV)
- Medical subject headings
- Bronchiolitis, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
Single-time sampling of respiratory virus-infected children
| Study group | Role | What they receive |
|---|---|---|
| Severe bronchiolitis | venous blood samples. Buccal, nasopharyngeal and rectal swabs Receives: Other: Sampling | |
| Non-hospitalized bronchiolitis | Capillary blood samples. Buccal, nasopharyngeal and rectal swabs Receives: Other: Sampling | |
| Bronchiolitis ihospitalized in ICU | Capillary blood samples. Buccal, nasopharyngeal and rectal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysbiosis
comparison of the quantitative and qualitative composition of bacteria (alpha diversity, beta diversity, Shannon and Simpson index) in the digestive and nasopharyngeal microbiota
Measured: Inclusion
Secondary outcomes (5)
Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasma
Inflammatory/regulatory cytokines (IL1->17, IL-10, TGF-b, EGF, FGF-2, IFN-alpha, IFN-gamma, IFN-beta, MCRP-1 MCP-3, TNF-alpha...), cytokines of adaptative response (Th1, Th17, Th2 and/or Treg), markers of inflammatory response (interferon, TNFa, …), quantified by Luminex
Measured: inclusion
Identifying the mRNA profile in blood samples and nasal swabs
mRNA will be identified by using RNA-Seq (Illumina)
Measured: inclusion
Sequencing viral strains for mutation
Typing of respiratory syncytial virus-A (RSV-A) and B (RSV-B) and sequencing of strains (Amplicons)
Measured: Inclusion
Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infection
Levels of RSV antibodies will be measured and compared between newborn screening specimen and capillary swab during infection
Measured: Birth, Inclusion
Study the load of Streptococcus pneumoniae (Sp) in RSV infections.
Compare the serotypic profiles of pneumococcus (Sp) present during RSV infections
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start6 Dec 2024
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Models for Innovative Therapies center
- Responsible party
- Sponsor
- Investigators
- Etienne BIZOT, Doctor, Principal investigator, AP-HP Hôpital Antoine Beclere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161285
- Sponsor's protocol ID
- APHP231177
- Other IDs
- 2023-A01688-37
- Acronym
- BRONCHOBIOTE
- Status last verified
- Jan 2025
- First submitted
- 30 Nov 2023
- Last updated
- 26 Feb 2025
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
- ClinicalTrials.gov ID
- NCT06161285
- Acronym / sponsor ID
- BRONCHOBIOTE / APHP231177
- Conditions
- Bronchiolitis
- Keywords
- Newborns, Dysbiosis, respiratory syncytial virus (RSV)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Infectious Diseases Models for Innovative Therapies center
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 Dec 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.
Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe bronchiolitis | – | Other: Samplingvenous blood samples. Buccal, nasopharyngeal and rectal swabs |
| Non-hospitalized bronchiolitis | – | Other: SamplingCapillary blood samples. Buccal, nasopharyngeal and rectal swabs |
| Bronchiolitis ihospitalized in ICU | – | –Capillary blood samples. Buccal, nasopharyngeal and rectal swabs |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Bronchiolitis in patient under 12 months old
Key inclusion criteria (5 listed)
- Infants <12 months
- With bronchiolitis during RSV epidemic season
- No chronic illness
- No bronchiolitis medical history
- Signed consent from parents or legal guardians
Key exclusion criteria (4 listed)
- Chronic respiratory illness
- Medical history of bronchiolitis or newborn asthma
- Treatment with immunosuppressants
- Patient with no social security affiliation
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 |
|---|---|---|
| SamplingSingle-time sampling of respiratory virus-infected children | Other | Non-hospitalized bronchiolitis, Severe bronchiolitis |
Primary outcome
Dysbiosis
Time frame: Inclusion
comparison of the quantitative and qualitative composition of bacteria (alpha diversity, beta diversity, Shannon and Simpson index) in the digestive and nasopharyngeal microbiota
5 secondary outcomes
Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasma
Time frame: inclusion
Identifying the mRNA profile in blood samples and nasal swabs
Time frame: inclusion
Sequencing viral strains for mutation
Time frame: Inclusion
Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infection
Time frame: Birth, Inclusion
Study the load of Streptococcus pneumoniae (Sp) in RSV infections.
Time frame: Inclusion
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 26 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Etienne BIZOT, Doctor principal investigator
AP-HP Hôpital Antoine Beclere
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 5 inclusion and 4 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 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Etienne BIZOT, Doctor (33145374618, etienne.bizot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysbiosis (time frame: Inclusion). 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 26 Feb 2025.