Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03079206
Recruitment Status : Active, not recruiting
First Posted : March 14, 2017
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
ADR-AC Laboratory, Berne
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components.

Condition or disease Intervention/treatment Phase
Food Allergy Diagnostic Test: Food challenge Diagnostic Test: skin testing Diagnostic Test: blood sampling Not Applicable

Detailed Description:

Accurate diagnosis of food allergy depends on food challenge outcome. The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components to evaluate the diagnostic utility of basophile activation testing.

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The study intends to compare the outcome of food challenge with hazelnut and the in vitro basophile activation test using hazelnut extract and allergens
Masking: None (Open Label)
Masking Description: In terms of study inclusion there will be no masking. Only the food challenge itself will be masked.
Primary Purpose: Diagnostic
Official Title: Correlation of the in Vivo Food Provocation Test With the in Vitro Basophile Activation Test in Hazelnut Allergic Patients
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hazelnut allergy
patients with positive case history of hazelnut allergy and a positive skin testing are undergoing a food challenge and blood sampling for basophile activation testing
Diagnostic Test: Food challenge
food challenge with hazelnut

Diagnostic Test: skin testing
Skin testing with hazelnut extract

Diagnostic Test: blood sampling
blood sampling to perform basophile activation tests




Primary Outcome Measures :
  1. Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test [ Time Frame: up to 3 years ]
    outcome of food challenge in hazelnut allergic patients will be compared to the outcome of basophile activation using hazelnut extract and allergens



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Primary Inclusion criteria:

  • Male and female subjects, age ≥ 14 years
  • Informed Consent as documented by signature

Secondary inclusion criterion

  • Group A: positive case history of allergic reaction(s) to hazelnut positive double-blind placebo-controlled food challenge with hazelnut or positive titrated open food challenge with hazelnut or unambiguous case history of an anaphylactic reaction after hazelnut will be included without provocation
  • Group B:positive skin test (SPT) with birch pollen and hazelnut and negative food provocation with hazelnut.
  • Group C: negative case history of hazelnut and birch allergy and negative skin test (SPT) with hazelnut and birch pollen and negative food provocation with hazelnut

Exclusion Criteria:

  • Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge): corticosteroids systemically (2 weeks), antihistamines (3 days), beta blocker (1 day), angiotensin converting enzyme (ACE) inhibitors (2 days), omalizumab (2 months)
  • Women who are pregnant
  • Lack of safe contraception
  • Uncontrolled asthma, forced expiratory volume (1 second) <70% predicted value
  • Acute allergic disease
  • Chronic urticaria
  • Mastocytosis
  • Other clinically significant concomitant disease states
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study
  • Participation in another study with investigational drug within the 30 days preceding and during the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079206


Locations
Layout table for location information
Switzerland
Allergy Unit, Department of Dermatology, University Hospital
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
ADR-AC Laboratory, Berne
Investigators
Layout table for investigator information
Principal Investigator: Barbara Ballmer-Weber, Prof. Allergy Unit, Department of Dermatology, University Zürich

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03079206     History of Changes
Other Study ID Numbers: 2016-02152
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
hazelnut
allergens
basophile-activation-test
food
allergy

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate