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Tiny lungs, big secrets: microbiome study aims to unlock severe infant asthma

NCT ID NCT06044051

Knowledge-focused Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the bacteria (microbiomes) in the airways of infants under 2 years old with severe asthma. Researchers will collect blood, nasal swabs, and sputum samples to understand how these microbiomes relate to the disease. The goal is to find new ways to improve care and discover potential treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could point toward new treatments for severe infant asthma, such as using azithromycin as an immune modulator.
What could go wrong
This is an observational study, not a treatment trial. It is small (100 infants) and early-stage, so findings may not lead directly to new therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 24 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

asthma childhood onset asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma Asthma in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rouen University Hospital

    RECRUITING

    Rouen, France

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