Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM)
|ClinicalTrials.gov Identifier: NCT02295397|
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : May 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Food Allergy||Other: food||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Integrated Approaches to Food Allergen and Allergy Risk Management|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: food provocation
open and placebo-controlled food challenges
food provocation, skin testing, blood sampling
- numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy [ Time Frame: November 2014 to February 2017, up to 27 months ]
- 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 ]
- 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 [ Time Frame: February 2015 to February 2017, up to 27 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295397
|Allergy Unit, Department of Dermatology, University Hospital|
|Zürich, Switzerland, 8091|
|Study Chair:||Clare Mills, Coordinator||University Manchester|