Bacterial Lysate In Preventing Asthma

• Status: Not yet recruiting
• Trial end date: 2025-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Bronchiolitis is a common viral infection of the small airways of infants and some affected infants will require hospital admission. Severe bronchiolitis is a marker for greatly increased risk of developing both preschool wheeze and subsequent school age asthma. Since epidemiological studies suggest that exposure to microbial products protects against preschool wheeze, lysates of bacteria may prevent the development of wheeze after bronchiolitis, with long-term beneficial consequences.

BLIPA is a phase IIb, randomised, double blind, placebo-controlled study, investigating the efficacy superiority of bacterial lysate (Broncho Vaxom) capsules over placebo, in reducing wheeze in infants after severe bronchiolitis. The primary end point of the study is parent-reported, healthcare-professional confirmed wheeze at 19-24 months. The study aims to test bacterial lysate capsules (3.5mg over 24 months) for safety, efficacy, and to advance mechanistic understanding of its action.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen Mary University of London
• Collaborator: Queensland University of Technology
• Treatments: Broncho-Vaxom

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 RCT. (Unless prior approval is given by PI)

• Sibling of a BLIPA participant (of the same household or family)