None listed
Conditions
Brief summary
Persistent asthma is a major problem yet none of the current therapies do more than control the condition. The long-term solution is to prevent asthma from progressing to the persistent form. The major risk factors are: family history, early allergy and recurrent severe lower respiratory infections (sLRI) in the early life. We will conduct a randomized clinical trial to prevent sLRI using a novel bacterial-derived immunostimulant (OM-85) in infants at high risk of developing asthma. OM-85 works by priming the immune system so that body can respond quickly to infections. This will help reduce damage to the lungs during sLRI's and may prevent asthma from developing.
Interventions
OM-85 capsule powder (3.5mg) in five blocks of 10 days treatment plus 20 days no treatment, during the first two winter viral seasons (April to September) of a child's life. Capsule powder can be dissolved in fruit juice, water or milk for administration. Parents/guardians will be contacted toward the start of each treatment block as a reminder. Parents/guardians will be given a calendar as a reminder to start treatment blocks and to record doses given or missed. Parents/guardians will return em
OM-85 capsule powder (3.5mg) in five blocks of 10 days treatment plus 20 days no treatment, during the first two winter viral seasons (April to September) of a child's life. Capsule powder can be dissolved in fruit juice, water or milk for administration. Parents/guardians will be contacted toward the start of each treatment block as a reminder. Parents/guardians will be given a calendar as a reminder to start treatment blocks and to record doses given or missed. Parents/guardians will return empty and full blister packs at study visits to monitor adherence.
Sponsors
Child Health Research Centre, University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
3 Months to 9 Months
Healthy volunteers
Yes
Inclusion criteria
1. Children of either sex, aged 3-9 months old whose biological mother, father, or sibling has a history of asthma and/or atopy (defined as SPT reactivity to one or more allergen, food allergy, atopic dermatitis or allergic rhinitis) 2. Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration 3. Written informed consent signed and dated by parent/legal guardian according to local regulations
Exclusion criteria
1. Children born less than 36 weeks gestation 2. Children who have been diagnosed with asthma 3. Children who have chronic pulmonary disease or other chronic disease (other than atopic dermatitis, food allergy, or chronic rhinitis) requiring therapy 4. Participation in another randomized controlled trial within the 3 months preceding inclusion in this study 5. Children who has previously received OM-85 or other immunostimulant or immunosuppressive drugs including cyclosporine
Outcome results
None listed