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

Primary Purpose

Food Allergy

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

food

About this trial

This is an interventional other trial for Food Allergy focused on measuring Food provocation, Matrix effect, ED05, Allergy, Proton Pump Inhibitor

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Allergy Unit, Department of Dermatology, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

food provocation

Arm Description

open and placebo-controlled food challenges

Outcomes

Primary Outcome Measures

numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy

Secondary Outcome Measures

numbers of patients reacting to a defined dose of peanut and hazelnut in titrated challenges

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

Full Information

NCT ID

NCT02295397

First Posted

November 11, 2014

Last Updated

May 10, 2017

Sponsor

University of Zurich

Collaborators

Cork University Hospital, Charite University, Berlin, Germany, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Nebraska Lincoln, Region Hovedstadens Apotek, Servicio Madrileño de Salud, Madrid, Spain, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

1. Study Identification

Unique Protocol Identification Number

NCT02295397

Brief Title

Integrated Approaches to Food Allergen and Allergy Risk Management

Acronym

iFAAM

Official Title

Integrated Approaches to Food Allergen and Allergy Risk Management

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

single shot study, matrix comparison and walnut/PPI study detailed case history, blood sampling and prick testing with different foods will performed. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Allergy

Keywords

Food provocation, Matrix effect, ED05, Allergy, Proton Pump Inhibitor

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

food provocation

Arm Type

Experimental

Arm Description

open and placebo-controlled food challenges

Intervention Type

Other

Intervention Name(s)

food

Intervention Description

food provocation, skin testing, blood sampling

Primary Outcome Measure Information:

Title

numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy

Time Frame

November 2014 to February 2017, up to 27 months

Secondary Outcome Measure Information:

Title

numbers of patients reacting to a defined dose of peanut and hazelnut in titrated challenges

Time Frame

November 2014 to February 2017, up to 27 months

Title

Time Frame

February 2015 to February 2017, up to 27 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clare Mills, Coordinator

Organizational Affiliation

University Manchester

Official's Role

Study Chair

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

Integrated Approaches to Food Allergen and Allergy Risk Management

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