Bacterial Lysate In Preventing Asthma

Launched by QUEEN MARY UNIVERSITY OF LONDON · Sep 21, 2021

Keywords

ClinConnect Summary

The BLIPA trial is studying whether a treatment called bacterial lysate (specifically, Broncho Vaxom capsules) can help reduce wheezing in infants who have experienced severe bronchiolitis, a common respiratory infection. The goal is to see if giving these capsules for two years can prevent wheezing and potentially reduce the risk of developing asthma later on. The study is looking for infants aged 3 to 12 months who have recently been hospitalized for bronchiolitis and whose parents can provide consent for them to participate.

If eligible, your child will be randomly assigned to receive either the bacterial lysate capsules or a placebo (a non-active pill) for 24 months. You will report any wheezing your child experiences, and healthcare professionals will confirm it. The study is currently recruiting participants, and it's an important step in understanding how bacterial products may help protect against respiratory issues in young children. Please remember that certain medical conditions and treatments may exclude your child from participating, so it’s best to discuss any concerns with your healthcare provider.

Gender

ALL

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)