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Recruiting NCT05710081

Bacterial Lysate In Preventing Asthma

Conditions: Wheezing, Bronchiolitis, Asthma in Children

Sex: All
Ages: 2 Weeks – 12 Months
Phase: PHASE3
Enrollment: 894
Sponsor: Barts & The London NHS Trust

Location: United Kingdom

Summary

The goal of this clinical trial is to learn about the effects of using bacterial lysate in bronchiolitis. The main question it aims to answer are:Does the use of bacterial lysate after bronchiolitis reduce the likelihood of preschool wheezeParticipants will take either the active medicine or a placebo for 24 months.

Eligibility Criteria

INCLUSION CRITERIAParent/Guardian able to provide written informed consentWithin 6 weeks of discharge from hospital following admission for bronchiolitisChild aged is ≥2 weeks of age and ≤ 12 months on the date of hospital admission for BronchiolitisA diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital)Contactable for regular follow up by the research teamEXCLUSION CRITERIAAny previous hospital attendance for bronchiolitisMore than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episodePremature gestational age less than 34 weeksAny 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 therapyCurrent 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05710081). StuddyBuddy aggregates publicly available trial information.