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Bacterial lysate shows promise in preventing infant wheeze after bronchiolitis

NCT ID NCT05064631

Prevention Sponsor: Queen Mary University of London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether a bacterial lysate (Broncho Vaxom) can prevent wheezing in infants who were hospitalized for severe bronchiolitis. 173 infants received either the lysate or a placebo for up to 24 months. The goal was to see if the treatment reduces the number of wheeze episodes in the first year.

What this could mean

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

Active substance
Bacterial lysate (Broncho Vaxom)
What this could lead to
If it works, this could point toward a simple way to prevent wheezing and asthma in infants after severe bronchiolitis.
What could go wrong
This is a small, early-phase trial (phase 2) with only 173 infants. The treatment may not reduce wheeze episodes, and long-term benefits are uncertain.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

173 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 2024

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

2 weeks to 12 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: * Parent/Guardian able to provide written informed consent * Within 6 weeks of discharge from hospital for bronchiolitis * Child aged ≥2 weeks and ≤12 months at the time of consent to study * A diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital) * Contactable for regular follow up by the research team Exclusion Criteria: * Any previous hospital attendance for bronchiolitis * More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode * Premature gestational age less than 37 weeks * Any severe chronic condition such as cystic fibrosis, sickle cell disease, severe developmental delay, immunodeficiency, or anything that has a significant impact on the respiratory tract (such as need for non-invasive ventilation) or increases vulnerability to respiratory tract infections. * History of clinically significant neonatal disease (e.g. neonatal pneumonia, congenital lung abnormality, neonatal chronic lung disease) * Genetic conditions that affect the immune system (e.g. Down's syndrome/Trisomy 21) * Current regular oral montelukast or inhaled corticosteroid therapy or inhaled salbutamol therapy * Current regular treatment with immunomodulatory drugs (e.g oral steroids) * Known allergy or previous intolerance to study medication. * Currently enrolled to another Randomised Clinical Trial. (Unless prior approval is given by Principal Investigator) * Sibling of a BLIPA participant (of the same household or family)

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Conditions

The condition(s) this trial relates to.

bronchiolitis Respiratory Sounds respiratory tract infectious disorder

As listed by the trial registrant

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

Pediatric respiratory diseases Respiratory tract infections Wheezing

Contacts and locations

Locations

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Royal London Hospital

    London, E1 1FR, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

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