NCT05064631CompletedPhase 2
Bacterial Lysate In Preventing Asthma
Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 173 (actual)
- First submitted
- 20 Aug 2021
- Start date
- Jan 2022
- Primary completion date
- Jun 2024
- Lead sponsor
- Queen Mary University of London
- Diseases
- Asthma
- NCT number
- NCT05064631
- EudraCT number
- 2021-000628-36
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 173
- From Jan 2022 to the primary completion date, Jun 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous hospital attendance for bronchiolitis
- More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode
- Current regular oral montelukast or inhaled corticosteroid therapy or inhaled salbutamol therapy
- Current regular treatment with immunomodulatory drugs (e.g oral steroids)
- Known allergy or previous intolerance to study medication.
- Currently enrolled to another Randomised Clinical Trial. (Unless prior approval is given by Principal Investigator)
Other illness
- 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.
- 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)
Age
- Premature gestational age less than 37 weeks
Other
- Sibling of a BLIPA participant (of the same household or family)
Who the study is looking for
- Parent/Guardian able to provide written informed consent
- Within 6 weeks of discharge from hospital for bronchiolitis
- Child aged ≥2 weeks and ≤12 months at the time of consent to study
- A diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital)
- Contactable for regular follow up by the research team
Age in the registry: 2 weeks to 12 months · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King's College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.