Clinical trial NCT02295397: Integrated Approaches to Food Allergen and Allergy Risk Management
Official title: Integrated Approaches to Food Allergen and Allergy Risk Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: Food provocation
Matrix effect
ED05
Allergy
Proton Pump Inhibitor
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Cork University Hospital
name: Charite University, Berlin, Germany
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: University of Nebraska Lincoln
name: Region Hovedstadens Apotek
name: Servicio Madrileño de Salud, Madrid, Spain
name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2014-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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.

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

Primary outcomes:
measure: numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy
timeFrame: November 2014 to February 2017, up to 27 months
Secondary outcomes:
measure: numbers of patients reacting to a defined dose of peanut and hazelnut in titrated challenges
timeFrame: November 2014 to February 2017, up to 27 months
measure: 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
timeFrame: February 2015 to February 2017, up to 27 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Allergy Unit, Department of Dermatology, University Hospital
Study officials:
affiliation: University Manchester
name: Clare Mills, Coordinator
role: STUDY_CHAIR
References: