Respiratory Tract InfectionsPhase 2BLIPANCT05064631
Bacterial Lysate In Preventing Asthma
A Phase 2 study testing Bacterial Lysate in people with Respiratory Tract Infections and Pediatric Respiratory Diseases, run by Queen Mary University of London at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 2 weeks to 12 months
- Conditions the study is for
- Respiratory Tract Infections, Pediatric Respiratory Diseases, Wheezing
- What is being tested?
- Bacterial Lysate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 12 Jan 2022to 13 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 participant (of the same household or family)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal London Hospital
London, E1 1FR
King's College Hospital NHS Foundation Trust
London, SE5 9RS
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
About this study
Official title: Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
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.
Read the detailed description
The BLIPA study aims to investigate the following research questions:
- In children hospitalised with bronchiolitis, does Oral Broncho-Vaxom reduce incidence of parent-reported wheeze during 12 months post IMP initiation after a hospital admission for bronchiolitis.
- Does oral BV reduces the risk of wheeze after bronchiolitis by modulating T cell and Dendritic cells (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-United Kingdom (UK), with recruitment in London, Southampton, Cheshire 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 (National Institute for Health and Care Research). BLIPA-Australia is funded in Australia by the International Clinical Trial Collaboration (ICTC). ICTC supports Australian researchers to conduct clinical trial research in collaboration with international researchers.
The total study duration is 74 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 12-24 months, follow up for 12-24 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 Investigational Medicinal Product (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 12-24 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.
- Being tested
- Bacterial Lysate
- Keywords
- Asthma in childhood, Bronchiolitis, Wheeze, Bacterial lysate
- Medical subject headings
- Respiratory Tract Infections, Respiratory Sounds, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial LysateDrug
Also called Broncho Vaxom
Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system.
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | Oral Broncho-Vaxom (3.5mg) administered daily for 10 days per month for 12-24 months Receives: Drug: Bacterial Lysate |
| Placebo control | Placebo comparator | Matched placebo administered daily for 10 days per month for 12-24 months Receives: Drug: Bacterial Lysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of a wheeze episodes by 12 months
To establish whether there is superiority of oral Broncho-Vaxom over placebo in the reduction of parent reported wheeze episodes by 12 months post IMP/placebo initiation
Measured: 12 months
Secondary outcomes (18)
To establish whether there is a difference between treatment with Broncho-Vaxom or placebo in healthcare professional confirmed wheeze episodes by 12 months post IMP initiation.
Wheeze confirmed via one of the following:
- Prescription for more than one salbutamol inhaler coded in primary care record between 0-12 months post IMP/placebo initiation.
- Active wheeze code in primary care records between 0-12 months post IMP/placebo initiation.
- Asthma diagnosis code in primary care records between 0-12 months post IMP/placebo initiation.
Measured: 12 months
Occurrence of hospital admissions for wheeze-related illness by 12 months.
Occurrence of hospital admissions for wheeze-related illness by 12 months.
Measured: 12 months
Occurrence of unscheduled medical attendance for wheeze-related illness by 12 months
Occurrence of unscheduled medical attendance for wheeze-related illness (rate[episodes per child/month] and yes/no).
Measured: 12 months
Presence of wheeze diagnosis by 12 months
Presence of wheeze diagnosis by 12 months
Measured: 12 months
Time to first wheeze episode by 12 months
Time to first wheeze episode by 12 months
Measured: 0-12 months
Duration of wheeze by 12 months
Duration of wheeze by 12 months
Measured: 12 months
Development of eczema by 12 months
Development of eczema by 12 months confirmed by parent report at study follow ups (parent reported outcome)
Measured: 12 months
Development of Dr-diagnosed food allergy by 12 months
Development of Dr-diagnosed food allergy by 12 months
Measured: 12 months
Occurrence of all-cause acute respiratory infection by 12 months
Occurrence of all-cause acute respiratory infection by 12 months
Measured: 12 months
Hospital admissions for respiratory related illness (rate[episodes per child-month] and yes/no) by 12 months
Hospital admissions for respiratory related illness (rate[episodes per child-month] and yes/no) by 12 months
Measured: 12 months
Quality of life confirmed by Warwick Child Health and Morbidity by 12 months
Quality of life confirmed by Warwick Child Health and Morbidity by 12 months
Measured: 12 months
Number of courses of oral corticosteroids for wheeze by 12 months
Number of courses of oral corticosteroids for wheeze by 12 months
Measured: 12 months
Incidence of adverse events (AEs) for the treatment group by 12 months
Number of AEs by 12 months
Measured: 12 months
Incidence of serious adverse events (SAEs) for the treatment group by 12 months
Number of SAEs by 12 months
Measured: 12 months
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group by 12 months
Number of SUSARs by 12 months
Measured: 12 months
Incidence of adverse events (AEs) for the treatment group between 0-24 months
Number of AEs across 0-24 months
Measured: 0-24 months
Incidence of serious adverse events (SAEs) for the treatment group between 0-24 months
Number of SAEs across 0-24 months
Measured: 0-24 months
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group between 0-24 months
Number of SUSARs across 0-24 months
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start12 Jan 2022
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children will be allocated into two arms (oral BV and placebo) in a 1:1 ratio. Randomisation will be stratified by site and parental asthma and the lists generated using random blocks of size 4 and 6.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Queensland University of Technology
- Responsible party
- Sponsor
- Investigators
- Jonathan Grigg, Prof. Dr, Study chair, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064631
- Sponsor's protocol ID
- 295882
- Other IDs
- 2021-000628-36
- Acronym
- BLIPA
- Status last verified
- May 2026
- First submitted
- 20 Aug 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05064631
- Acronym / sponsor ID
- BLIPA / 295882
- Keywords
- Asthma in childhood, Bronchiolitis, Wheeze, Bacterial lysate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Queensland University of Technology
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The BLIPA study aims to investigate the following research questions:
- In children hospitalised with bronchiolitis, does Oral Broncho-Vaxom reduce incidence of parent-reported wheeze during 12 months post IMP initiation after a hospital admission for bronchiolitis.
- Does oral BV reduces the risk of wheeze after bronchiolitis by modulating T cell and Dendritic cells (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-United Kingdom (UK), with recruitment in London, Southampton, Cheshire 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 (National Institute for Health and Care Research). BLIPA-Australia is funded in Australia by the International Clinical Trial Collaboration (ICTC). ICTC supports Australian researchers to conduct clinical trial research in collaboration with international researchers.
The total study duration is 74 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 12-24 months, follow up for 12-24 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 Investigational Medicinal Product (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 12-24 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Children will be allocated into two arms (oral BV and placebo) in a 1:1 ratio. Randomisation will be stratified by site and parental asthma and the lists generated using random blocks of size 4 and 6.
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Drug: Bacterial LysateOral Broncho-Vaxom (3.5mg) administered daily for 10 days per month for 12-24 months |
| Placebo control | Placebo comparator | Drug: Bacterial LysateMatched placebo administered daily for 10 days per month for 12-24 months |
Who may qualify
- Ages
- 2 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterial LysateAlso: Broncho VaxomBacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system. | Drug | Active intervention, Placebo control |
Primary outcome
Number of a wheeze episodes by 12 months
Time frame: 12 months
To establish whether there is superiority of oral Broncho-Vaxom over placebo in the reduction of parent reported wheeze episodes by 12 months post IMP/placebo initiation
18 secondary outcomes
To establish whether there is a difference between treatment with Broncho-Vaxom or placebo in healthcare professional confirmed wheeze episodes by 12 months post IMP initiation.
Time frame: 12 months
Occurrence of hospital admissions for wheeze-related illness by 12 months.
Time frame: 12 months
Occurrence of unscheduled medical attendance for wheeze-related illness by 12 months
Time frame: 12 months
Presence of wheeze diagnosis by 12 months
Time frame: 12 months
Time to first wheeze episode by 12 months
Time frame: 0-12 months
Duration of wheeze by 12 months
Time frame: 12 months
Development of eczema by 12 months
Time frame: 12 months
Development of Dr-diagnosed food allergy by 12 months
Time frame: 12 months
Occurrence of all-cause acute respiratory infection by 12 months
Time frame: 12 months
Hospital admissions for respiratory related illness (rate[episodes per child-month] and yes/no) by 12 months
Time frame: 12 months
Quality of life confirmed by Warwick Child Health and Morbidity by 12 months
Time frame: 12 months
Number of courses of oral corticosteroids for wheeze by 12 months
Time frame: 12 months
Incidence of adverse events (AEs) for the treatment group by 12 months
Time frame: 12 months
Incidence of serious adverse events (SAEs) for the treatment group by 12 months
Time frame: 12 months
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group by 12 months
Time frame: 12 months
Incidence of adverse events (AEs) for the treatment group between 0-24 months
Time frame: 0-24 months
Incidence of serious adverse events (SAEs) for the treatment group between 0-24 months
Time frame: 0-24 months
Incidence of Suspected unexpected serious adverse reactions (SUSARs) for the treatment group between 0-24 months
Time frame: 0-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Grigg, Prof. Dr study chair
Queen Mary University of London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bacterial Lysate in people with Respiratory Tract Infections and Pediatric Respiratory Diseases, run by Queen Mary University of London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of a wheeze episodes by 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.