Prevalence of Food Allergies to Proteins From Different Legumes

This study has been completed.
Sponsor:
Collaborators:
SRH Wald-Klinikum Gera gGmbH
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01728168
First received: November 12, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Food Allergy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Evidence of a sensitization to legume proteins [ Time Frame: 20 minutes after skin prick ] [ Designated as safety issue: Yes ]
    Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)


Enrollment: 183
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728168

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

No publications provided

Responsible Party: Gerhard Jahreis, Prof. Dr. habil., University of Jena
ClinicalTrials.gov Identifier: NCT01728168     History of Changes
Other Study ID Numbers: LSEP H54-12
Study First Received: November 12, 2012
Last Updated: February 3, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 16, 2014