Clinical Trials Logo

Clinical Trial 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 IIb, 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 is parent-reported, healthcare-professional confirmed wheeze at 19-24 months. The study aims to test bacterial lysate capsules (3.5mg over 24 months) for safety, efficacy, and to advance mechanistic understanding of its action.

Clinical Trial Description

The BLIPA study aims to investigate the following research questions: 1. In children hospitalised with bronchiolitis, does oral Broncho Vaxom (BV) given for 10 days per month for a total of 24 months, prevent parent-reported, healthcare professional-confirmed, wheeze between 19 and 24 months post initiation of IMP/placebo. 2. Does oral BV reduces the risk of wheeze after bronchiolitis by modulating T cell and DC maturation and altering the gut and airway microbiota. (mechanistic hypothesis) The BLIPA study will combine the results of two multi-centre, randomised trials with similar but separate protocols: BLIPA-UK, with recruitment in London, Southampton, Edinburgh, and Aberdeen and BLIPA-Australia, with recruitment in Brisbane, Gold Coast, Melbourne, Darwin and Sydney. BLIPA-UK is funded in the UK by the NIHR. BLIPA-Australia is funded in Australia by the ICTC initiative. ICTC supports Australian researchers to conduct clinical trial research in collaboration with international researchers. The total study duration is 54 months. The primary clinical objective is to recruit a population of eligible participants, to randomise them to oral Broncho Vaxom (3.5mg) or placebo, to be taken daily for 10 days a month over 24 months, follow up for 24 months and compare primary and secondary outcomes between trial arms. Parents or guardians of children, clinicians involved in their care and trial staff will be blinded to the treatment arm. Recruitment will be for 18 months and children's outcomes will be assessed for 24 months following initiation of IMP or placebo. Within six weeks of hospital discharge following admission for bronchiolitis, parents or guardians can consent to their child partaking in the study, baseline data is collected, the child is randomised, and the IMP or placebo is initiated (12 months' supply). From the point of treatment initiation, children are followed up for 24 months, the same length as the treatment period. There will be at least one scheduled face to face visit at 12 months to dispense a further year's supply of IMP or placebo. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05064631
Study type Interventional
Source Queen Mary University of London
Contact Jonathan Grigg, Prof. Dr
Phone 00447789397850
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 19, 2021
Completion date October 30, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04583280 - A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) Phase 3
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Active, not recruiting NCT03251196 - TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
Not yet recruiting NCT05024890 - The Impact of a School-based WASH Intervention on Child Health and School Attendance in Addis Ababa, Ethiopia N/A
Completed NCT02561871 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers Phase 1
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT01419262 - DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers Phase 3
Completed NCT00984945 - Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults Phase 1
Completed NCT00127686 - Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Phase 1
Active, not recruiting NCT01107223 - Long Term Effect of General Practitioner Education on Antibiotic Prescribing N/A
Completed NCT03739112 - Efficacy of a Plant-derived Quadrivalent VLP Vaccine in the Elderly Phase 3
Completed NCT04144491 - Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda N/A
Recruiting NCT04170348 - Daily Vitamin D for Sickle-cell Respiratory Complications Phase 2
Completed NCT04525040 - ProbioKid as Prevention Among Kids With Frequent URTI N/A
Recruiting NCT04547556 - ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms N/A
Completed NCT04806477 - Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients. N/A
Completed NCT04533685 - Patient Portal Reminder/Recall for Influenza Vaccination in a Health System- UCLA Portal R/R Influenza RCT 3 N/A
Recruiting NCT03840603 - Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department N/A