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

April 3, 2006 updated by: The Netherlands Asthma Foundation
The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508AB
        • Wilhelmina Children's Hospital (UMCU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence and severity of atopic disease.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Asthma Foundation

Investigators

  • Principal Investigator: Maarten O Hoekstra, MD PhD, Wilhelmina Children's Hospital Utrecht (UMCU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 4, 2006

Last Update Submitted That Met QC Criteria

April 3, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3.2.93.96.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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