Molecular Analysis of IgE Antibodies in Walnut Allergic Patients

Food Allergy Clinical Trial

Official title:

Molecular Analysis of IgE Antibodies in Walnut Allergic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295267
• Other study ID #: 2012-0519
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: May 10, 2017
• Start date: December 2012
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.

Description:

Accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). Thus, full characterization of the major allergens of walnut and their clinical importance is an important undertaking.

The proposed study intends to investigate and compare the pattern of IgE antibody sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen reagents.

With a view towards improved in vitro diagnostic methods, we intend to evaluate the diagnostic potential of recombinant walnut allergens in patients with walnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to walnut in the past, patients with pollinosis but no symptoms of walnut allergy and non-atopic control subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• Group A: positive case history of allergic reaction(s) to walnut

• Group B: positive case history of allergy to birch, grass or olive pollen and no case history of allergic reaction(s) to walnut

• Group C: no case history of atopic disease

Exclusion Criteria:

• Known pregnancy

• Breast-feeding of infant

• Treatment with the following drugs (or shortest interval between last treatment and food challenge or SPT):

• corticosteroids (2 weeks): applied systemically, to the nose or locally on the skin test area.

• antihistamines (3 days) except hydroxyzine (10 days)

• betablocker agents (1 day)

• angiotensin converting enzyme inhibitors (2 days)

• Any major organic or infectious disease

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity

Intervention

Other:
• walnut allergy provocation
double blind placebo controlled food challenge

Locations

Country	Name	City	State
Switzerland	Allergy Unit, Department of Dermatology, University Hospital	Zürich

Sponsors (5)

Lead Sponsor	Collaborator
University of Zurich	Hospital Clinic of Barcelona, Paul Ehrlich Institute Langen, St. Marien Hospital Bonn, Thermo Fisher Scientific

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numbers of patients with walnut allergy		December 2012 to November 2017, up to 5 years