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Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM)

This study has been completed.
Sponsor:
Collaborators:
Cork University Hospital
Charite University, Berlin, Germany
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Nebraska Lincoln
Region Hoverstaden
Servicio Madrileño de Salud, Madrid, Spain
Institut National de la Recherche Agronomique
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02295397
First received: November 11, 2014
Last updated: May 10, 2017
Last verified: May 2017
  Purpose

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 Intervention
Food Allergy
Other: food

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Participant, Investigator
Primary Purpose: Other
Official Title: Integrated Approaches to Food Allergen and Allergy Risk Management

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • numbers of patients reacting to ED05 in hazelnut, walnut, celeriac allergy [ Time Frame: November 2014 to February 2017, up to 27 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: November 2014
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: food provocation
open and placebo-controlled food challenges
Other: food
food provocation, skin testing, blood sampling

Detailed Description:

single shot study, matrix comparison and walnut/PPI 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.
  Eligibility

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02295397

Locations
Switzerland
Allergy Unit, Department of Dermatology, University Hospital
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Cork University Hospital
Charite University, Berlin, Germany
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Nebraska Lincoln
Region Hoverstaden
Servicio Madrileño de Salud, Madrid, Spain
Institut National de la Recherche Agronomique
Investigators
Study Chair: Clare Mills, Coordinator University Manchester
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02295397     History of Changes
Other Study ID Numbers: iFAAM
Study First Received: November 11, 2014
Last Updated: May 10, 2017

Keywords provided by University of Zurich:
Food provocation
Matrix effect
ED05
Allergy
Proton Pump Inhibitor

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 25, 2017