Skip to main content
OpenTrials
Completed

NCT Number: NCT00200928

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Food Allergy Asthma Atopic Dermatitis Bronchial Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Food Hypersensitivity Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilhelmina Children's Hospital (UMCU)

Utrecht, 3508AB, Netherlands

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BCG

Biological

Primary outcomes

  1. Incidence and severity of atopic disease.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

The Netherlands Asthma Foundation

Other

Registry information

Important dates

Study start
1999
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Apr 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.