Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | April 3, 2006 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Incidence and severity of atopic disease. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00200928 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood. | ||||
| Official Title ICMJE | Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood. | ||||
| 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. |
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| 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) |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Biological: BCG | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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) |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00200928 | ||||
| Other Study ID Numbers ICMJE | 3.2.93.96.2 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | The Netherlands Asthma Foundation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Netherlands Asthma Foundation | ||||
| Verification Date | April 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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