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Prevalence of Food Allergies to Proteins From Different Legumes

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ClinicalTrials.gov Identifier: NCT01728168
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : February 4, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.

Condition or disease
Food Allergy

Study Design

Study Type : Observational
Actual Enrollment : 183 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Food Allergies to Proteins From Different Legumes (Lupin, Peanut, Soy, and Pea) in Atopic and Healthy Subjects
Study Start Date : December 2012
Primary Completion Date : July 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Atopic
Subjects with either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (>10 points).
Non-atopic
Subjects without atopy.


Outcome Measures

Primary Outcome Measures :
  1. Evidence of a sensitization to legume proteins [ Time Frame: 20 minutes after skin prick ]
    Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.
Criteria
  1. Inclusion Criteria:

    • Male and female subjects
    • Age 18 up to 75 years
    • For group "Atopic": either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (>10 points).
  2. Exclusion Criteria:

    • Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids
    • Acute allergic symptoms
    • Skin infections at the test side
    • Pregnancy, lactation
    • Acute inflammatory diseases
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728168


Locations
Germany
SRH Wald-Klinikum Gera gGmbH
Gera, Thuringia, Germany, 07548
Sponsors and Collaborators
University of Jena
SRH Wald-Klinikum Gera GmbH
German Federal Ministry of Education and Research
Investigators
Study Director: Martin Kaatz, Dr. med. SRH Wald-Klinikum Gera GmbH
More Information

Responsible Party: Gerhard Jahreis, Prof. Dr. habil., University of Jena
ClinicalTrials.gov Identifier: NCT01728168     History of Changes
Other Study ID Numbers: LSEP H54-12
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Gerhard Jahreis, University of Jena:
lupin
peanut
soy
pea
legumes
cross-reactivity
sensitization
atopy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate