<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01728168</url>
  </required_header>
  <id_info>
    <org_study_id>LSEP H54-12</org_study_id>
    <nct_id>NCT01728168</nct_id>
  </id_info>
  <brief_title>Prevalence of Food Allergies to Proteins From Different Legumes</brief_title>
  <official_title>Prevalence of Food Allergies to Proteins From Different Legumes (Lupin, Peanut, Soy, and Pea) in Atopic and Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SRH Wald-Klinikum Gera GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Jena</source>
  <brief_summary>
    <textblock>
      The objective of the study is to assess the prevalence of a sensitization to proteins from&#xD;
      legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material&#xD;
      (lupin) in atopic and healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of a sensitization to legume proteins</measure>
    <time_frame>20 minutes after skin prick</time_frame>
    <description>Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">183</enrollment>
  <condition>Food Allergy</condition>
  <arm_group>
    <arm_group_label>Atopic</arm_group_label>
    <description>Subjects with either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (&gt;10 points).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-atopic</arm_group_label>
    <description>Subjects without atopy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Inclusion Criteria:&#xD;
&#xD;
               -  Male and female subjects&#xD;
&#xD;
               -  Age 18 up to 75 years&#xD;
&#xD;
               -  For group &quot;Atopic&quot;: either documented allergy, neurodermatitis, allergic asthma,&#xD;
                  allergic rhinitis, and/or a positive atopic score based on the criteria of&#xD;
                  Erlangen (&gt;10 points).&#xD;
&#xD;
          2. Exclusion Criteria:&#xD;
&#xD;
               -  Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids&#xD;
&#xD;
               -  Acute allergic symptoms&#xD;
&#xD;
               -  Skin infections at the test side&#xD;
&#xD;
               -  Pregnancy, lactation&#xD;
&#xD;
               -  Acute inflammatory diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Kaatz, Dr. med.</last_name>
    <role>Study Director</role>
    <affiliation>SRH Wald-Klinikum Gera GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SRH Wald-Klinikum Gera gGmbH</name>
      <address>
        <city>Gera</city>
        <state>Thuringia</state>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>February 3, 2014</last_update_submitted>
  <last_update_submitted_qc>February 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jena</investigator_affiliation>
    <investigator_full_name>Gerhard Jahreis</investigator_full_name>
    <investigator_title>Prof. Dr. habil.</investigator_title>
  </responsible_party>
  <keyword>lupin</keyword>
  <keyword>peanut</keyword>
  <keyword>soy</keyword>
  <keyword>pea</keyword>
  <keyword>legumes</keyword>
  <keyword>cross-reactivity</keyword>
  <keyword>sensitization</keyword>
  <keyword>atopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728168
org study id: LSEP H54-12
nct id: NCT01728168
lead sponsor: 
collaborator: 
collaborator: 
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Evidence of a sensitization to legume proteins
time frame: 20 minutes after skin prick
description: Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)
arm group label: Atopic
description: Subjects with either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (>10 points).
arm group label: Non-atopic
description: Subjects without atopy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Kaatz, Dr. med.
role: Study Director
affiliation: SRH Wald-Klinikum Gera GmbH
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Jena
investigator full name: Gerhard Jahreis
investigator title: Prof. Dr. habil.
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity