NCT00200928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

April 4, 2006

Status Verified

April 1, 2006

First QC Date

September 12, 2005

Last Update Submit

April 3, 2006

Conditions

Food AllergyAtopic DermatitisAsthmaRhinitis

Keywords

prospectiverandomisedinterventionBCGatopy

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of atopic disease.

Secondary Outcomes (1)

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

Interventions

BCGBIOLOGICAL

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.

You may not qualify if:

  • maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilhelmina Children's Hospital (UMCU)

Utrecht, Utrecht, 3508AB, Netherlands

Location

Related Links

MeSH Terms

Conditions

Food HypersensitivityDermatitis, AtopicAsthmaRhinitis

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityRespiratory Tract InfectionsInfectionsNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Maarten O Hoekstra, MD PhD

    Wilhelmina Children's Hospital Utrecht (UMCU)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 1999

Study Completion

July 1, 2005

Last Updated

April 4, 2006

Record last verified: 2006-04

Locations

NL(1)