Integrated Approaches to Food Allergen and Allergy Risk Management

NCT02295397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-05-11

No results posted yet for this study

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

Interventions

OTHER

food

food provocation, skin testing, blood sampling

Sponsors & Collaborators

  • Cork University Hospital

    collaborator OTHER
  • Charite University, Berlin, Germany

    collaborator OTHER
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER
  • University of Nebraska Lincoln

    collaborator OTHER
  • Region Hovedstadens Apotek

    collaborator OTHER_GOV
  • Servicio Madrileño de Salud, Madrid, Spain

    collaborator OTHER
  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    collaborator OTHER
  • University of Zurich

    lead OTHER

Principal Investigators

  • Clare Mills, Coordinator · University Manchester

Study Design

Allocation
NA
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02295397 on ClinicalTrials.gov