Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.|
- Incidence and severity of atopic disease.
- SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
|Study Start Date:||January 1999|
|Estimated Study Completion Date:||July 2005|
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200928
|Wilhelmina Children's Hospital (UMCU)|
|Utrecht, Netherlands, 3508AB|
|Principal Investigator:||Maarten O Hoekstra, MD PhD||Wilhelmina Children's Hospital Utrecht (UMCU)|