A new trial is set to examine whether boosting the immune system by using an orally administered bacteria lysate could prevent wheeze in preschool children and potentially future childhood asthma.
Queensland University of Technology (QUT) will lead the $1.6 million Australian-UK world-first project which is due to start in September 2021.
Over the next five years, researchers will give more than 900 infants, recruited from across Australia and the UK, oral Broncho Vaxom (BV), a lysate of respiratory bacteria, to test if it reduces the incidence of doctor-diagnosed wheeze 18-24 months post-hospitalisation for bronchiolitis.
The trial is targeting children aged 3-12 months at the time of consent to study, who have had a diagnosis of bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital) and are contactable for regular follow up by the research team.
Acute bronchiolitis is a common viral lower respiratory tract infection that causes inflammation of the small airways in infants aged less than 12-months.
Bronchiolitis is the leading cause of hospitalisation in Australian infants, resulting in about 13,500 admissions each year. In the UK, more than 30,000 infants are hospitalised with the condition.
“The most severe cases can be triggered by the common cold – human rhinovirus and respiratory syncytial virus,” said Professor Anne Chang, lead investigator from the QUT School of Public Health & Social Work, and program lead for cough, asthma and airways research at the Australian Centre for Health Services Innovation (AusHSI).
Preventing the development of wheeze in preschool children could produce major health benefits, including the prevention of asthma and other atopic conditions, but to date no therapies have proved to be effective.
“Epidemiological investigations suggest exposure to microbial products protects against preschool wheeze, and thus, bacterial lysates may prevent wheeze developing after severe bronchiolitis,” Professor Chang said.
Stopping post-bronchiolitis wheeze could prevent up to 5,400 new asthma cases per year in children in Australia and 12,000 cases in the UK.
If the trial is successful, Professor Chang said BV could become a standard treatment available for those at risk of preschool wheeze and asthma.
Funding is through the Medical Research Future Fund (MRFF) Clinical Trials Activity – International Clinical Trials Collaborations grant that supports Australian involvement in international collaborative investigator-initiated clinical trials.
The study is in conjunction with Professor Jonathan Grigg’s group at the Queen Mary University London, UK.