Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02295397
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2014-11-11
Brief Title:
Integrated Approaches to Food Allergen and Allergy Risk Management
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Integrated Approaches to Food Allergen and Allergy Risk Management
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iFAAM
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
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 walnutPPI 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None