Bacterial Lysate In Preventing Asthma (NCT05064631) | Clinical Trial Compass
CompletedPhase 2
Bacterial Lysate In Preventing Asthma
United Kingdom173 participantsStarted 2022-01-12
Plain-language 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.
Who can participate
Age range
2 Weeks – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Any previous hospital attendance for bronchiolitis
* More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode
* Premature gestational age less than 37 weeks
* 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)
* 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)
* Sibling of a BLIPA partici…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial testing a bacterial lysate in children with wheezing — since Phase 2 studies are mainly focused on safety and early effectiveness signals rather than definitive proof, what does that mean for how confident we can be in the results when deciding on a treatment approach for my child?
2The trial measured whether the bacterial lysate reduced the number of wheeze episodes over 12 months and has now completed — has my doctor seen or heard anything about what the results showed, and do those results change how they'd think about this as an option?
3Since this trial involved bacterial lysates, which are typically given orally to try to train the immune system, how does that approach compare to the standard treatments my child is already on or could start, like inhaled corticosteroids or bronchodilators?
4This trial focused on children with wheezing and respiratory tract infections — given my child's specific history and age, does my doctor think the profile of kids in this study is a close enough match to my child's situation to make the findings relevant to us?
5Now that this trial is completed, are there any follow-up or Phase 3 studies planned that might give us more definitive evidence, and should we be looking into those instead of acting on Phase 2 results alone?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.