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Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200928
First Posted: September 20, 2005
Last Update Posted: April 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Netherlands Asthma Foundation
September 12, 2005
September 20, 2005
April 4, 2006
January 1999
Not Provided
Incidence and severity of atopic disease.
Same as current
Complete list of historical versions of study NCT00200928 on ClinicalTrials.gov Archive Site
SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
Same as current
Not Provided
Not Provided
 
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
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.

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)

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
  • Food Allergy
  • Atopic Dermatitis
  • Asthma
  • Rhinitis
Biological: BCG
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2005
Not Provided

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)

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00200928
3.2.93.96.2
Not Provided
Not Provided
Not Provided
Not Provided
The Netherlands Asthma Foundation
Not Provided
Principal Investigator: Maarten O Hoekstra, MD PhD Wilhelmina Children's Hospital Utrecht (UMCU)
The Netherlands Asthma Foundation
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP