PATURE IV: Protection Against Allergy: Study in Rural Environment - Part IV

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT02929277

Collaborator

(none)

131

Enrollment

Arm

19.1

Duration (Months)

Study Details

Study Description

Brief Summary

PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133 children (farmers in about half of the children) to study the origins of asthma and atopy and to develop potential preventive strategies.

Previous results show a protective effect of farm exposure on allergic risk by livestock contacts and microbial exposures and by raw cow milk consumption in early age.

PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis) and to explain how early age exposures and particularly milk products consumption contribute in the process of allergic illness in childhood. A focus on the characterization of the protective biologically active components in raw milk and identification of immunological mechanisms are involved.

Condition or Disease	Intervention/Treatment	Phase
Asthma Atopy	Other: blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

131 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 6, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: single arm study	Other: blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires

Arm

Intervention/Treatment

Other: single arm study

Other: blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires

Outcome Measures

Primary Outcome Measures

Asthma [10 years old]
Rhinitis [10 years old]
Atopic Dermatitis [10 years old]
Food Allergy [10 years old]
Skin prick tests [10 years old]
Specific Immunoglobulin E (IgEs) [10 years old]
Blood cytokine profiles [10 years old]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

PATURE IV is a birth cohort. All children enrolled at the beginning and who still agree to participate will be included at 10-year follow-up.

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02929277

Other Study ID Numbers:

R/2012/47

First Posted:

Oct 11, 2016

Last Update Posted:

Jul 30, 2018

Last Verified:

Oct 1, 2016

Keywords provided by Centre Hospitalier Universitaire de Besancon

farm children

non-farm children

Study Results

No Results Posted as of Jul 30, 2018