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

Not Applicable

Completed

• Conditions: Food Allergy; Atopic Dermatitis; Asthma; Rhinitis

• Registration Number: NCT00200928
• Lead Sponsor: The Netherlands Asthma Foundation

Brief 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.

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)

Study Timeline

• Study Start: 1999-01
• Study Completion: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2006-04
• Last Update Submitted: 2006-04-03
• Last Update Posted: 2006-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence and severity of atopic disease.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wilhelmina Children's Hospital (UMCU); 🇳🇱 Utrecht, Netherlands