Asthma, a Disease Due to a Lack of Bacterial Infections i... | NCT00200928

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

NCT00200928

Sponsor

The Netherlands Asthma Foundation

Status

Completed

Last Update Posted

Apr 4, 2006Estimated

Enrollment

120

Phase

Not Applicable

Conditions

Food Allergy
Atopic Dermatitis
Asthma
Rhinitis

Interventions

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2006

Last Update Posted Date

Apr 4, 2006Estimated

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
BCG	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of atopic disease.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maarten O Hoekstra, MD PhD	Wilhelmina Children's Hospital Utrecht (UMCU)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wilhelmina Children's Hospital (UMCU)		Utrecht	Utrecht	3508AB	Netherlands

Label	URL
click for more information: Indiaan onderzoek	View source

Condition Browse Module

MeSH Terms

ID	Term
D005512	Food Hypersensitivity
D003876	Dermatitis, Atopic
D001249	Asthma
D012220	Rhinitis

Ancestor Terms

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided