Molecular Analysis of IgE Antibodies in Walnut Allergic Patients

NCT ID: NCT02295267

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-03-31

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.

Conditions

Food Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

walnut allergy provocation

inclusion of walnut allergic patients, food provocation with walnut

Group Type: EXPERIMENTAL

walnut allergy provocation

Intervention Type: OTHER

double blind placebo controlled food challenge

Interventions

walnut allergy provocation

double blind placebo controlled food challenge

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paul Ehrlich Institute Langen

UNKNOWN

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

St. Marien Hospital Bonn

UNKNOWN

Sponsor Role: collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Ballmer-Weber, PI

Role: PRINCIPAL_INVESTIGATOR

Allergy Unit, Department of Dermatology, University Zürich

Locations

Allergy Unit, Department of Dermatology, University Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2012-0519

Identifier Type: -

Identifier Source: org_study_id