Prevalence of Food Allergies to Proteins From Different Legumes

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728168
• Other study ID #: LSEP H54-12
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: February 3, 2014
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Germany	SRH Wald-Klinikum Gera gGmbH	Gera	Thuringia

Sponsors (3)

Lead Sponsor	Collaborator
University of Jena	German Federal Ministry of Education and Research, SRH Wald-Klinikum Gera

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of a sensitization to legume proteins	Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)	20 minutes after skin prick	Yes