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Bacterial Lysate In Preventing Asthma

NCT05064631 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infections
  • Pediatric Respiratory Diseases
  • Wheezing

Interventions

DRUG

Bacterial Lysate

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

Sponsors & Collaborators

  • Queensland University of Technology

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Jonathan Grigg, Prof. Dr · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2024-06-13
Completion
2024-06-13

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064631 on ClinicalTrials.gov