Integrated Approaches to Food Allergen and Allergy Risk Management
NCT02295397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2017-05-11
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.
Conditions
Interventions
- OTHER
-
food
food provocation, skin testing, blood sampling
Sponsors & Collaborators
-
Cork University Hospital
collaborator OTHER -
Charite University, Berlin, Germany
collaborator OTHER -
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
collaborator OTHER -
University of Nebraska Lincoln
collaborator OTHER -
Region Hovedstadens Apotek
collaborator OTHER_GOV -
Servicio Madrileño de Salud, Madrid, Spain
collaborator OTHER -
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
collaborator OTHER -
University of Zurich
lead OTHER
Principal Investigators
-
Clare Mills, Coordinator · University Manchester
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- Switzerland
Study Locations
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