Back to resultsMolecular Analysis of IgE Antibodies in Walnut Allergic Patients
Primary Purpose
Food Allergy
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
walnut allergy provocation
Sponsored by
About this trial
This is an interventional diagnostic trial for Food Allergy focused on measuring Food allergy, Walnut, Components, Allergens
Eligibility 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
Sites / Locations
- Allergy Unit, Department of Dermatology, University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
walnut allergy provocation
Arm Description
inclusion of walnut allergic patients, food provocation with walnut
Outcomes
Primary Outcome Measures
numbers of patients with walnut allergy
Secondary Outcome Measures
Full Information
NCT ID
NCT02295267
First Posted
November 11, 2014
Last Updated
May 10, 2017
Sponsor
University of Zurich
Collaborators
Paul Ehrlich Institute Langen, Hospital Clinic of Barcelona, St. Marien Hospital Bonn, Thermo Fisher Scientific, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02295267
Brief Title
Molecular Analysis of IgE Antibodies in Walnut Allergic Patients
Official Title
Molecular Analysis of IgE Antibodies in Walnut Allergic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Paul Ehrlich Institute Langen, Hospital Clinic of Barcelona, St. Marien Hospital Bonn, Thermo Fisher Scientific, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Food allergy, Walnut, Components, Allergens
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
walnut allergy provocation
Arm Type
Experimental
Arm Description
inclusion of walnut allergic patients, food provocation with walnut
Intervention Type
Other
Intervention Name(s)
walnut allergy provocation
Intervention Description
double blind placebo controlled food challenge
Primary Outcome Measure Information:
Title
numbers of patients with walnut allergy
Time Frame
December 2012 to November 2017, up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Ballmer-Weber, PI
Organizational Affiliation
Allergy Unit, Department of Dermatology, University Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Unit, Department of Dermatology, University Hospital
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Molecular Analysis of IgE Antibodies in Walnut Allergic Patients
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