Bacterial Lysate In Preventing Asthma

Launched by BARTS & THE LONDON NHS TRUST · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called bacterial lysate can help prevent wheezing in young children who have recently been hospitalized for bronchiolitis, a lung infection. The main question is if taking this treatment can lower the chances of developing wheeze as the child grows. Participants in the study will take either the bacterial lysate or a placebo (a dummy treatment that looks the same but has no active ingredients) for two years.

To be eligible for this trial, children must be between 2 weeks and 12 months old and have been discharged from the hospital after being treated for bronchiolitis. Their parent or guardian must be able to provide consent and stay in touch with the research team for follow-ups. It's important to note that children with certain health conditions or previous wheezing episodes may not qualify. If selected, families can expect regular check-ins and support from the research team throughout the study period.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • 1. Parent/Guardian able to provide written informed consent
• • 2. Within 6 weeks of discharge from hospital following admission for bronchiolitis
• • 3. Child aged is ≥2 weeks of age and ≤ 12 months on the date of hospital admission for Bronchiolitis
• • 4. A diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital)
• • 5. Contactable for regular follow up by the research team
• • EXCLUSION CRITERIA
• • 1. Any previous hospital attendance for bronchiolitis
• • 2. More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode
• • 3. Premature gestational age less than 34 weeks
• • 4. 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.
• • 5. History of clinically significant neonatal disease (e.g. neonatal pneumonia, congenital lung abnormality, neonatal chronic lung disease)
• • 6. Genetic conditions that affect the immune system (e.g. Down's syndrome/Trisomy 21)
• • 7. Current regular oral montelukast or inhaled corticosteroid therapy or inhaled salbutamol therapy
• • 8. Current regular treatment with immunomodulatory drugs (e.g oral steroids)
• • 9. Known allergy or previous intolerance to study medication.
• • 10. Enrolment in another clinical trial of a medicinal product. Non-CTIMP study participation is allowed.
• • 11. Sibling of a BLIPA participant (of the same household or family)