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Completed

NCT Number: NCT02929277

Protection Against Allergy: Study in Rural Environment - Part 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.

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Key information

Conditions

Asthma Atopy Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

10 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Other

Primary outcomes

  1. Asthma

    Time frame: 10 years old

  2. Rhinitis

    Time frame: 10 years old

  3. Atopic Dermatitis

    Time frame: 10 years old

  4. Food Allergy

    Time frame: 10 years old

  5. Skin prick tests

    Time frame: 10 years old

  6. Specific Immunoglobulin E (IgEs)

    Time frame: 10 years old

  7. Blood cytokine profiles

    Time frame: 10 years old

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: PATURE IV

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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