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Trial record 9 of 50 for:    Open Studies | "Food Hypersensitivity"
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Prevalence of Food Allergies to Proteins From Different Legumes

This study is currently recruiting participants.
Verified December 2012 by University of Jena
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: December 17, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

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)


Estimated Enrollment: 150
Study Start Date: December 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Atopic
Atopic Subjects
Healthy
Healthy Subjects

  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 Atopia or healthy Subjects.

Criteria

Inclusion Criteria:

  • Male and female subjects
  • Age 18 up to 75 years
  • Group "Atopic": documented allergy, neurodermatitis, pollinosis

Exclusion Criteria:

  • Intake of antihistamine, sedative, antidepressants, beta-blocker, prednisolone, immunosuppressors
  • Acute allergical symptomes
  • Pregnancy, lactation
  • Acute inflammatory diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728168

Contacts
Contact: Gerhard Jahreis, Prof. Dr. +(49)3641/949610 b6jage@uni-jena.de
Contact: Melanie Bähr, Dipl.-Troph. +(49)3641/949610 b4bame@uni-jena.de

Locations
Germany
SRH Wald-Klinikum Gera gGmbH Recruiting
Gera, Thuringia, Germany, 07548
Contact: Martin Kaatz, Dr. med.     +(49)365/8287758        
Contact: Nancy Schmidt            
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: December 17, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 19, 2013