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OpenTrials
Completed

NCT Number: NCT02295397

Integrated Approaches to Food Allergen and Allergy Risk Management

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.

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Key information

Conditions

Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allergy Unit, Department of Dermatology, University Hospital

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food

Other

food provocation, skin testing, blood sampling

Primary outcomes

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

    Time frame: November 2014 to February 2017, up to 27 months

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

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

Registry information

Acronym: iFAAM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2014
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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