Using bacterial lysate to prevent asthma in children after bronchiolitis

Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial

This study is testing if taking bacterial lysate capsules can help prevent wheezing in infants who were hospitalized for severe bronchiolitis.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 894 (estimated)
• Ages: 3 Months to 12 Months
• Sex: All
• Sponsor: Queen Mary University of London (other)
• Locations: 3 sites (London and 2 other locations)
• Trial ID: NCT05064631 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of bacterial lysate capsules in preventing wheezing in infants who have been hospitalized for severe bronchiolitis. It is a phase 2b, randomized, double-blind, placebo-controlled trial that will administer Broncho Vaxom capsules for 10 days each month over a period of 24 months. The primary outcome will be measured through parent-reported and healthcare professional-confirmed wheeze at 19-24 months post-initiation. The study also aims to explore the mechanisms by which bacterial lysate may influence immune responses and microbiota in the gut and airways.

Who should consider this trial

Good fit: Ideal candidates are infants aged 3-12 months who have been hospitalized for bronchiolitis within the last 6 weeks.

Not a fit: Patients with a history of multiple wheezing episodes or severe chronic respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of asthma and wheezing in children who have experienced severe bronchiolitis.

How similar studies have performed: Previous studies have suggested that exposure to microbial products can protect against wheeze, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* Parent/Guardian able to provide written informed consent
* Within 6 weeks of discharge from hospital for bronchiolitis
* Child aged 3-12 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)

Where this trial is running

London and 2 other locations

• Royal London Hospital — London, United Kingdom (RECRUITING)
• King's College Hospital NHS Foundation Trust — London, United Kingdom (RECRUITING)
• University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Jonathan Grigg, Prof. Dr

Conditions: Respiratory Tract Infections, Pediatric Respiratory Diseases, Wheezing, Asthma in childhood, Bronchiolitis, Wheeze, Bacterial lysate