ActivePhase 2ACTRN12621001556831

The Efficacy of Bacterial Lysate in Prevention of Asthma

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

Sponsor

Queensland University of Technology

Enrollment

172 participants

Start Date

Feb 21, 2022

Study Type

Interventional

Conditions

Respiratory Tract Infections Wheezing

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 rate of parent-reported wheeze episodes. The study aims to test bacterial lysate capsules (3.5mg over 12-24 months) for safety, efficacy, and to advance mechanistic understanding of its action.

Eligibility

Sex: Both males and femalesMin Age: 2 WeekssMax Age: 12 Monthss

Inclusion Criteria5

Parent/Guardian able to provide written informed consent
Within 6 weeks of discharge from hospital for bronchiolitis
Child aged 2 weeks to 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 Criteria11

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 34 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)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Treatment: Drugs - Bacterial Lysate. Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system. Experimental: Active intervention

Treatment: Drugs - Bacterial Lysate. Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system. Experimental: Active intervention - Oral Broncho-Vaxom (3.5mg) administered daily for 10 (preferably consecutive) days per month for up to 24 months as oral powder mixed with food. Adherence monitored through dosing diary and to return the completed diary to site on a monthly basis.