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Molecular Analysis of IgE Antibodies in Walnut Allergic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Zurich
Sponsor:
Collaborators:
Paul Ehrlich Institute Langen
Hospital Clinic of Barcelona
St. Marien Hospital Bonn
Thermo Fisher Scientific
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02295267
First received: November 11, 2014
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Food Allergy
Other: walnut allergy provocation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Molecular Analysis of IgE Antibodies in Walnut Allergic Patients

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • numbers of patients with walnut allergy [ Time Frame: December 2012 to November 2017, up to 5 years ]

Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: walnut allergy provocation
inclusion of walnut allergic patients, food provocation with walnut
Other: walnut allergy provocation
double blind placebo controlled food challenge

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.

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02295267

Contacts
Contact: Barbara Ballmer-Weber, PI +41 2553976 barbara.ballmer@usz.ch

Locations
Switzerland
Allergy Unit, Department of Dermatology, University Hospital Recruiting
Zürich, Switzerland, 8091
Contact: Barbara Ballmer-Weber, Prof, MD    +41442553976    barbara.ballmer@usz.ch   
Principal Investigator: Barbara Ballmer-Weber, Prof, MD         
Sponsors and Collaborators
University of Zurich
Paul Ehrlich Institute Langen
Hospital Clinic of Barcelona
St. Marien Hospital Bonn
Thermo Fisher Scientific
Investigators
Principal Investigator: Barbara Ballmer-Weber, PI Allergy Unit, Department of Dermatology, University Zürich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02295267     History of Changes
Other Study ID Numbers: 2012-0519
Study First Received: November 11, 2014
Last Updated: October 26, 2016

Keywords provided by University of Zurich:
Food allergy
Walnut
Components
Allergens

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 28, 2017