Bacterial Lysate In Preventing Asthma (BLIPA)
Wheezing, Bronchiolitis, Asthma in Children
About this trial
This is an interventional prevention trial for Wheezing focused on measuring bacterial lysate, placebo, wheeze, allergy, asthma
Eligibility Criteria
INCLUSION CRITERIA Parent/Guardian able to provide written informed consent Within 6 weeks of discharge from hospital following admission for bronchiolitis Child aged is ≥2 weeks of age and ≤ 12 months on the date of hospital admission for Bronchiolitis 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 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. Enrolment in another clinical trial of a medicinal product. Non-CTIMP study participation is allowed. Sibling of a BLIPA participant (of the same household or family)
Sites / Locations
- Barts Health NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention
Placebo
Bacterial Lysate - Broncho-Vaxom (OM-85) 3.5mg granules once daily for 10 days per month for 24 months
Placebo - 3.5mg granules once daily for 10 days per month for 24 months