Molecular Analysis of IgE Antibodies in Walnut Allergic Patients

May 10, 2017 updated by: University of Zurich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

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

  • Switzerland
      • Zürich, Switzerland, 8091
        • Allergy Unit, Department of Dermatology, University Hospital

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

1 year to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: walnut allergy provocation
inclusion of walnut allergic patients, food provocation with walnut
Other: walnut allergy provocation
double blind placebo controlled food challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
numbers of patients with walnut allergy
Time Frame: December 2012 to November 2017, up to 5 years
December 2012 to November 2017, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Hospital Clinic of Barcelona
Thermo Fisher Scientific, Inc
Paul Ehrlich Institute Langen
St. Marien Hospital Bonn

Investigators

  • Principal Investigator: Barbara Ballmer-Weber, PI, Allergy Unit, Department of Dermatology, University Zürich

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)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0519

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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