Integrated Approaches to Food Allergen and Allergy Risk M... | NCT02295397

Studies
Integrated Approaches to Food Allergen and Allergy Risk Management

NCT02295397

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 11, 2017Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Food Allergy

Interventions

food

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Nov 11, 2014

First Submission Date that Met QC Criteria

Nov 14, 2014

First Posted Date

Nov 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2017

Last Update Posted Date

May 11, 2017Actual

Name	Class
Cork University Hospital	OTHER
Charite University, Berlin, Germany	OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
food provocation	Experimental	open and placebo-controlled food challenges	Other: food

Interventions

Name	Type	Description	Arm Group Labels	Other Names
food	Other	food provocation, skin testing, blood sampling	food provocation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy		November 2014 to February 2017, up to 27 months

Secondary Outcomes

Measure	Description	Time Frame
numbers of patients reacting to a defined dose of peanut and hazelnut in titrated challenges		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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clare Mills, Coordinator	University Manchester	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allergy Unit, Department of Dermatology, University Hospital		Zurich		8091	Switzerland

ID	Term
D005512	Food Hypersensitivity
D006967	Hypersensitivity

ID	Term
D006969	Hypersensitivity, Immediate
D007154	Immune System Diseases

ID	Term
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages