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Dynamics of Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma (Microbiosthme)

Primary Purpose

Asthma in Children, Asthma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood sample
Expectoration
Nasopharyngeal swab
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma in Children focused on measuring microbiosme, Asthma in infant

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    All patients

    Arm Description

    All patients included will be followed for 1 year, every 3 months

    Outcomes

    Primary Outcome Measures

    description of microbiomes from bronchoalveolar fluids
    analysis of bronchoalveolar fluids - NGS sequencing
    description of microbiomes from nasopharyngeal samples
    analysis of nasopharyngeal samples- NGS sequencing
    description of microbiomes from sputum samples
    analysis of sputum samples- NGS sequencing
    description of microbiomes from bronchoalveolar fluids
    analysis of bronchoalveolar fluids- NGS sequencing
    description of microbiomes from nasopharyngeal samples
    analysis of nasopharyngeal samples- NGS sequencing
    description of microbiomes from sputum samples
    analysis of sputum samples- NGS sequencing
    description of microbiomes from bronchoalveolar fluids
    analysis of bronchoalveolar fluids- NGS sequencing
    description of microbiomes from nasopharyngeal samples
    analysis of nasopharyngeal samples- NGS sequencing
    description of microbiomes from sputum samples
    analysis of sputum samples- NGS sequencing
    description of microbiomes from bronchoalveolar fluids
    analysis of bronchoalveolar fluids - NGS sequencing
    description of microbiomes from nasopharyngeal samples
    analysis of nasopharyngeal samples- NGS sequencing
    description of microbiomes from sputum samples
    analysis of sputum samples- NGS sequencing
    description of microbiomes from bronchoalveolar fluids
    analysis of bronchoalveolar fluids- NGS sequencing
    description of microbiomes from nasopharyngeal samples
    analysis of nasopharyngeal samples- NGS sequencing
    Description of microbiomes from sputum samples
    analysis of sputum samples- NGS sequencing

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    September 18, 2023
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06044051
    Brief Title
    Dynamics of Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
    Acronym
    Microbiosthme
    Official Title
    Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 26, 2023 (Anticipated)
    Primary Completion Date
    September 26, 2026 (Anticipated)
    Study Completion Date
    September 26, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this project is to establish the nature of potential dysbiosis, the interrelation of the different microbiomes of the respiratory tract, and the potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment. The aim of exploring and understanding these data is to ultimately improve patient care and discover new therapeutic targets. Indeed, modification of the microbiota was a therapeutic target even before it was discovered, and its immunomodulatory properties reinforce this position. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma in Children, Asthma
    Keywords
    microbiosme, Asthma in infant

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    All patients
    Arm Type
    Other
    Arm Description
    All patients included will be followed for 1 year, every 3 months
    Intervention Type
    Other
    Intervention Name(s)
    Blood sample
    Intervention Description
    An additionnal volume of blood will be collected at inclusion and at each follow-up visit
    Intervention Type
    Other
    Intervention Name(s)
    Expectoration
    Intervention Description
    Expectoration will be collected at inclusion and at each follow-up visit
    Intervention Type
    Other
    Intervention Name(s)
    Nasopharyngeal swab
    Intervention Description
    A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum
    Primary Outcome Measure Information:
    Title
    description of microbiomes from bronchoalveolar fluids
    Description
    analysis of bronchoalveolar fluids - NGS sequencing
    Time Frame
    Inclusion
    Title
    description of microbiomes from nasopharyngeal samples
    Description
    analysis of nasopharyngeal samples- NGS sequencing
    Time Frame
    Inclusion
    Title
    description of microbiomes from sputum samples
    Description
    analysis of sputum samples- NGS sequencing
    Time Frame
    Inclusion
    Title
    description of microbiomes from bronchoalveolar fluids
    Description
    analysis of bronchoalveolar fluids- NGS sequencing
    Time Frame
    at 3 months
    Title
    description of microbiomes from nasopharyngeal samples
    Description
    analysis of nasopharyngeal samples- NGS sequencing
    Time Frame
    at 3 months
    Title
    description of microbiomes from sputum samples
    Description
    analysis of sputum samples- NGS sequencing
    Time Frame
    at 3 months
    Title
    description of microbiomes from bronchoalveolar fluids
    Description
    analysis of bronchoalveolar fluids- NGS sequencing
    Time Frame
    at 6 months
    Title
    description of microbiomes from nasopharyngeal samples
    Description
    analysis of nasopharyngeal samples- NGS sequencing
    Time Frame
    at 6 months
    Title
    description of microbiomes from sputum samples
    Description
    analysis of sputum samples- NGS sequencing
    Time Frame
    at 6 months
    Title
    description of microbiomes from bronchoalveolar fluids
    Description
    analysis of bronchoalveolar fluids - NGS sequencing
    Time Frame
    at 9 months
    Title
    description of microbiomes from nasopharyngeal samples
    Description
    analysis of nasopharyngeal samples- NGS sequencing
    Time Frame
    at 9 months
    Title
    description of microbiomes from sputum samples
    Description
    analysis of sputum samples- NGS sequencing
    Time Frame
    at 9 months
    Title
    description of microbiomes from bronchoalveolar fluids
    Description
    analysis of bronchoalveolar fluids- NGS sequencing
    Time Frame
    at 12 months
    Title
    description of microbiomes from nasopharyngeal samples
    Description
    analysis of nasopharyngeal samples- NGS sequencing
    Time Frame
    at 12 months
    Title
    Description of microbiomes from sputum samples
    Description
    analysis of sputum samples- NGS sequencing
    Time Frame
    at 12 months

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Mallet
    Phone
    02 32 88 82 65
    Ext
    +33
    Email
    secretariat.DRC@chu-rouen.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ËTAT Hortense
    Organizational Affiliation
    Rouen University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Dynamics of Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma

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