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

T

The Netherlands Asthma Foundation

Status

Completed

Conditions

Atopic Dermatitis
Food Allergy
Asthma
Rhinitis

Treatments

Biological: BCG

Study type

Interventional

Funder types

Other

Identifiers

NCT00200928
3.2.93.96.2

Details and patient eligibility

About

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

Full 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)

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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