Integrated Approaches to Food Allergen and Allergy Risk Management

NCT02295397 | Completed

• 1 other identifier: iFAAM
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Food provocation; Matrix effect; ED05; Allergy; Proton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

• numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy

  November 2014 to February 2017, up to 27 months

Secondary Outcomes (2)

• 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

  February 2015 to February 2017, up to 27 months

Study Arms (1)

food provocation

EXPERIMENTAL

open and placebo-controlled food challenges

Other: food

Interventions

food OTHER

food provocation, skin testing, blood sampling

food provocation

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Cork University Hospital: collaborator
• Charite University, Berlin, Germany: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• University of Nebraska Lincoln: collaborator
• Region Hovedstadens Apotek: collaborator
• Servicio Madrileño de Salud, Madrid, Spain: collaborator
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator

Study Sites (1)

Allergy Unit, Department of Dermatology, University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity

Interventions

Food

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Clare Mills, Coordinator

  University Manchester

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

CH (1)