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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014