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ACTIVE NOT RECRUITING
NCT05064631
PHASE2

Bacterial Lysate In Preventing Asthma

Sponsor: Queen Mary University of London

View on ClinicalTrials.gov

Summary

Bronchiolitis is a common viral infection of the small airways of infants and some affected infants will require hospital admission. Severe bronchiolitis is a marker for greatly increased risk of developing both preschool wheeze and subsequent school age asthma. Since epidemiological studies suggest that exposure to microbial products protects against preschool wheeze, lysates of bacteria may prevent the development of wheeze after bronchiolitis, with long-term beneficial consequences. BLIPA is a phase 2b, randomised, double blind, placebo-controlled study, investigating the efficacy superiority of bacterial lysate (Broncho Vaxom) capsules over placebo, in reducing wheeze in infants after severe bronchiolitis. The primary end point of the study to establish whether there is superiority of oral Broncho-Vaxom over placebo in reducing the number of parent-reported wheeze episodes by 12 months post IMP/placebo initiation. The study aims to test bacterial lysate capsules (3.5mg over 12-24 months) for safety, efficacy, and to advance mechanistic understanding of its action.

Official title: Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial

Key Details

Gender

All

Age Range

2 Weeks - 12 Months

Study Type

INTERVENTIONAL

Enrollment

173

Start Date

2022-01-12

Completion Date

2026-01-30

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Bacterial Lysate

Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system.

Locations (3)

Royal London Hospital

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom