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

N/ACompletedNCT00200928

The Netherlands Asthma Foundation120 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Food Allergy Atopic Dermatitis Asthma Rhinitis

Interventions

BCGBIOLOGICAL

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

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)

Locations (1)

Wilhelmina Children's Hospital (UMCU)

Utrecht, Utrecht, Netherlands

Outcomes

Primary Outcomes

Incidence and severity of atopic disease.

Secondary Outcomes

SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.

Data from ClinicalTrials.gov

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