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NCT00200928 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00200928
Other study ID # 3.2.93.96.2
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated April 3, 2006
Start date January 1999
Est. completion date July 2005

Study information
Verified date April 2006
Source The Netherlands Asthma Foundation
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• BCG

Locations
Country Name City State
Netherlands Wilhelmina Children's Hospital (UMCU) Utrecht

Sponsors (1)
Lead Sponsor Collaborator
The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and severity of atopic disease.
Secondary SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
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