- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02929277
Protection Against Allergy: Study in Rural Environment - Part IV (PATURE IV)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: single arm study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Asthma
Time Frame: 10 years old
|
10 years old
|
Rhinitis
Time Frame: 10 years old
|
10 years old
|
Atopic Dermatitis
Time Frame: 10 years old
|
10 years old
|
Food Allergy
Time Frame: 10 years old
|
10 years old
|
Skin prick tests
Time Frame: 10 years old
|
10 years old
|
Specific Immunoglobulin E (IgEs)
Time Frame: 10 years old
|
10 years old
|
Blood cytokine profiles
Time Frame: 10 years old
|
10 years old
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R/2012/47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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