Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Barts & The London NHS Trust
- Enrollment
- 894
- Locations
- 1
- Primary Endpoint
- Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
Study Overview
Brief Summary
The goal of this clinical trial is to learn about the effects of using bacterial lysate in bronchiolitis. The main question it aims to answer are:
Does the use of bacterial lysate after bronchiolitis reduce the likelihood of preschool wheeze
Participants will take either the active medicine or a placebo for 24 months.
Detailed Description
To establish whether there is superiority of oral BV (broncho vaxom) over placebo in the prevention of parent-reported, healthcare professional-confirmed, persistent wheeze between 19 and 24 months post initiation of IMP/placebo, after a hospital admission for severe bronchiolitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Weeks to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention
Bacterial Lysate - Broncho-Vaxom (OM-85) 3.5mg granules once daily for 10 days per month for 24 months
Intervention: Bacterial Lysate (Biological)
Placebo
Placebo - 3.5mg granules once daily for 10 days per month for 24 months
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
Time Frame: 24 months
Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
Secondary Outcomes
- Use of medication(24 months)
- Asthma or Wheeze Diagnosis(24 months)
- Unscheduled Medical attendances(24 months)
- Number of courses of oral steroids(24 months)
- Montelukast use(24 months)
- Number of courses of antibiotics(24 months)
- Eczema diagnosis(24 months)
- Safety and Tolerability(24 months)