NCT00503048

Brief Summary

There are many studies regarding possible causes of increasing trend in frequency of allergic diseases in the last three decades. Main causes of this trend are: decrease of infectious diseases frequency, improvement in life level, changes in diet and lactic acid bacterias elimination from digestive tract. Primary Purpose of this study is to compare the prevalence of atopy and atopic diseases in two child populations: foster care and reference children and - to define risk and protective factors for the development of atopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
915

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

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

December 1, 2003

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 25, 2008

Status Verified

December 1, 2008

Enrollment Period

3.8 years

First QC Date

July 17, 2007

Last Update Submit

December 23, 2008

Conditions

Atopic Diseases

Keywords

atopyatopic diseaseschildrenorphanages

Study Arms (2)

1

foster care children

2

reference children (living with families)

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children.

You may qualify if:

  • must be able to make spirometry

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland

Lodz, 93-513, Poland

Location

Related Publications (2)

  • Stelmach I, Smejda K, Kaczmarek J, Stelmach W, Kuna P. [Prevalence of atopy and atopic diseases in children living in an orphanage in Lodz area--pilot study]. Pol Merkur Lekarski. 2006 May;20(119):531-4. Polish.

    PMID: 16875155RESULT

  • Stelmach I, Smejda K, Jerzynska J, Stelmach W, Majak P, Stelmach P, Kuna P. Decreased markers of atopy in children with presumed early exposure to allergens, unhygienic conditions, and infections. Ann Allergy Asthma Immunol. 2007 Aug;99(2):170-7. doi: 10.1016/S1081-1206(10)60641-2.

    PMID: 17718105RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood samples

Study Officials

  • Katarzyna Smejda, MD

    Department of Pediatrics and Allergy, Medical University of Lodz, Poland

    PRINCIPAL INVESTIGATOR

  • Iwona Stelmach, MD, PhD, Prof

    Department of Pediatrics and Allergy, Medical University of Lodz, Poland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

December 1, 2003

Primary Completion

October 1, 2007

Study Completion

November 1, 2007

Last Updated

December 25, 2008

Record last verified: 2008-12

Locations

PL(1)