Asthma, Atopic Dermatitis, Food Allergy, Rhinitis
Conditions
Keywords
prospective, randomised, intervention, BCG, atopy
Brief summary
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
Detailed description
A randomised single blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo. Inclusion: high-risk was defined as either a mother or a father and a sibling with present or past atopic disease. Exclusion: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother), the use of antibiotics directly post-partum (newborn)
Interventions
BIOLOGICALBCG
Sponsors
The Netherlands Asthma Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.
Exclusion criteria
maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of atopic disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms. | — |
Countries
Netherlands
Outcome results
None listed