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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
  Purpose
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.

Condition Intervention
Food Allergy Atopic Dermatitis Asthma Rhinitis Biological: BCG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.

Resource links provided by NLM:


Further study details as provided by The Netherlands Asthma Foundation:

Primary Outcome Measures:
  • Incidence and severity of atopic disease.

Secondary Outcome Measures:
  • SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.

Estimated Enrollment: 120
Study Start Date: January 1999
Estimated Study Completion Date: July 2005
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200928


Locations
Netherlands
Wilhelmina Children's Hospital (UMCU)
Utrecht, Netherlands, 3508AB
Sponsors and Collaborators
The Netherlands Asthma Foundation
Investigators
Principal Investigator: Maarten O Hoekstra, MD PhD Wilhelmina Children's Hospital Utrecht (UMCU)
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00200928     History of Changes
Other Study ID Numbers: 3.2.93.96.2
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: April 4, 2006
Last Verified: April 2006

Keywords provided by The Netherlands Asthma Foundation:
prospective
randomised
intervention
BCG
atopy

Additional relevant MeSH terms:
Asthma
Rhinitis
Dermatitis
Dermatitis, Atopic
Eczema
Bacterial Infections
Food Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous


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