- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728168
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
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).
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSEP H54-12
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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