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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2005-07-31

Brief Summary

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

Detailed Description

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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)

Conditions

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Food Allergy Atopic Dermatitis Asthma Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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BCG

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Maarten O Hoekstra, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Wilhelmina Children's Hospital Utrecht (UMCU)

Locations

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Wilhelmina Children's Hospital (UMCU)

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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3.2.93.96.2

Identifier Type: -

Identifier Source: org_study_id