Prevalence of Food Allergies to Proteins From Different Legumes

February 3, 2014 updated by: Gerhard Jahreis, University of Jena

Prevalence of Food Allergies to Proteins From Different Legumes (Lupin, Peanut, Soy, and Pea) in Atopic and Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • SRH Wald-Klinikum Gera gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
20 minutes after skin prick

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Martin Kaatz, Dr. med., SRH Wald-Klinikum Gera GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

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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