Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM)

Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food provocation with a dose of the allergenic food to which 5% of the respective food allergic population (ED05) has been calculated to respond with allergic reactions (single shot study).

In patients with a hazelnut or peanut allergy a double-blind placebo controlled food challenge with cookies containing either placebo or hazelnut and peanut respectively will be performed to determine threshold levels eliciting an allergic reaction. The results for threshold levels determined by cookie matrix will be compared to the results gained from the EuroPrevall project (matrix comparison study).

In patients with a walnut allergy double-blind placebo controlled provocation with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on the threshold level and on the clinical manifestation.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Other: food

Detailed Description

single shot study, matrix comparison and walnut/PPI study

1. detailed case history, blood sampling and prick testing with different foods will performed.
2. food provocation with a chocolate dessert meal containing either hazelnut, walnut or celeriac (ED05) will be performed (single shot study) in patients with a positive case history of an allergic reaction to either hazelnut, walnut or celeriac or with two meals containing either placebo or hazelnut and peanut respectively in hazelnut and peanut allergic patients or with three meals containing either placebo or walnut in walnut allergic patients.
3. in patients with a negative single shot challenge an open provocation with native hazelnut, walnut, celeriac will be performed unless the patients do not have had a positive previous food provocation with the respective food. In patients with a negative double-blind placebo-controlled food challenge an open provocation with hazelnut or peanut or walnut will be performed to confirm tolerance.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent
• For single shot study: history of a hazelnut, walnut, celeriac allergy due to an unequivocal accidental exposure with typical acute allergic reaction within the preceding 2 years and positive allergen-specific skin prick test/specific Immunoglobulin E or recent positive oral food challenge with hazel, walnut or celeriac within previous 2 years in children <16 years, but no time limit specified for adults
• For matrix comparison study: history of peanut or hazelnut allergy
• For walnut/PPI study: history of walnut allergy. The minimum age for this study is 18 years

Exclusion Criteria:

• Severe disease (heart, liver, kidney), acute febrile infection
• Intake of Ketotifen (past 2 weeks), corticosteroids (past 2 weeks), histamine-1-receptor blocker (past 3 days apart first generation past 7 days)
• Anaphylactic reaction (past 4 weeks)
• Uncontrolled bronchial asthma, forced expiratory volume < 70% predicted
• Pregnancy
• Acute infection or allergy
• Uncontrolled atopic dermatitis
• Chronic urticaria
• Mastocytosis
• Uncontrolled hypertension

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: food provocation; open and placebo-controlled food challenges	Other: food; food provocation, skin testing, blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy	November 2014 to February 2017, up to 27 months

Secondary Outcome Measures

Outcome Measure	Time Frame
numbers of patients reacting to a defined dose of peanut and hazelnut in titrated challenges	November 2014 to February 2017, up to 27 months
Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole	February 2015 to February 2017, up to 27 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Charite University, Berlin, Germany; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Cork University Hospital; Institut National de la Recherche Agronomique; Servicio Madrileño de Salud, Madrid, Spain; University of Nebraska Lincoln; Region Hovedstadens Apotek
• Investigators: Study Chair: Clare Mills, Coordinator, University Manchester

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 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: Allergy; Proton Pump Inhibitor; Food provocation; Matrix effect; ED05
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: iFAAM