Back to resultsAsthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
Primary Purpose
Food Allergy, Atopic Dermatitis, Asthma
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
BCG
Sponsored by
About this trial
This is an interventional prevention trial for Food Allergy focused on measuring prospective, randomised, intervention, BCG, atopy
Eligibility Criteria
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)
Sites / Locations
- Wilhelmina Children's Hospital (UMCU)
Outcomes
Primary Outcome Measures
Incidence and severity of atopic disease.
Secondary Outcome Measures
SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
Full Information
NCT ID
NCT00200928
First Posted
September 12, 2005
Last Updated
April 3, 2006
Sponsor
The Netherlands Asthma Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00200928
Brief Title
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
Official Title
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Netherlands Asthma Foundation
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Atopic Dermatitis, Asthma, Rhinitis
Keywords
prospective, randomised, intervention, BCG, atopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
BCG
Primary Outcome Measure Information:
Title
Incidence and severity of atopic disease.
Secondary Outcome Measure Information:
Title
SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten O Hoekstra, MD PhD
Organizational Affiliation
Wilhelmina Children's Hospital Utrecht (UMCU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilhelmina Children's Hospital (UMCU)
City
Utrecht
ZIP/Postal Code
3508AB
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://www.kinderallergologie.nl/
Description
click for more information: Indiaan onderzoek
Learn more about this trial
Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
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