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

This study has been completed.
Sponsor:
Information provided by:
The Netherlands Asthma Foundation
ClinicalTrials.gov Identifier:
NCT00200928
First received: September 12, 2005
Last updated: April 3, 2006
Last verified: April 2006
History of Changes
  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
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.

Resource links provided by NLM:

U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
click for more information: Indiaan onderzoek  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00200928     History of Changes
Other Study ID Numbers: 3.2.93.96.2
Study First Received: September 12, 2005
Last Updated: April 3, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on May 22, 2013