NCT02929277

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
Last Updated

July 30, 2018

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

September 30, 2016

Last Update Submit

July 26, 2018

Conditions

Keywords

farm childrennon-farm children

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (1)

single arm study

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

Interventions

Eligibility Criteria

Age10 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Chauveau A, Dalphin ML, Mauny F, Kaulek V, Schmausser-Hechfellner E, Renz H, Riedler J, Pekkanen J, Karvonen AM, Lauener R, Roduit C, Vuitton DA, von Mutius E, Dalphin JC; PASTURE Study Group. Skin prick tests and specific IgE in 10-year-old children: Agreement and association with allergic diseases. Allergy. 2017 Sep;72(9):1365-1373. doi: 10.1111/all.13148. Epub 2017 Apr 12.

  • Chauveau A, Dalphin ML, Kaulek V, Roduit C, Pugin A, von Mutius E, Vuitton DA, Dalphin JC. Disagreement between Skin Prick Tests and Specific IgE in Early Childhood. Int Arch Allergy Immunol. 2016;170(2):69-74. doi: 10.1159/000446776. Epub 2016 Jul 26.

MeSH Terms

Conditions

Asthma

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 11, 2016

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 6, 2015

Last Updated

July 30, 2018

Record last verified: 2016-10