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Role of Recombinants in Peach Allergy

This study has been completed.
Information provided by (Responsible Party):
Niguarda Hospital Identifier:
First received: July 14, 2008
Last updated: February 20, 2012
Last verified: February 2012
This study is aimed at verifying the role and the efficacy of the recombinants allergens Pru p 1, Pru p 3 and Pru p 4, Bet v 1, Bet v 2 and Bet v 4 in the diagnosis of peach allergy

Food Allergy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Classification of Different Forms of Peach Allergy and the Role of Recombinant Allergens in the Diagnosis

Resource links provided by NLM:

Further study details as provided by Niguarda Hospital:

Primary Outcome Measures:
  • Evaluation of diagnostic efficacy of PHADIA IMMUNO-CAP with the peach recombinant allergens Pru p 3, 1 and 4 as compared to peach IMMUNO-CAP in the identification of peach allergic subjects at major risk of anaphylaxis [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood sample

Enrollment: 148
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Subjects with mild (S1) reaction to peach fruit
Subjects with severe reaction to peach fruit

Detailed Description:

This study intend to verify whether the different levels of severity of the clinical allergic reactions to peach are associated to sensitization towards different allergenic molecules of peach. In particular, we will analyze the reactivity towards the peach allergens Pru p 1, Pru p 3 and Pru p 4 and towards the birch pollen allergens Bet v 1, Bet v 2 and Bet v 4. The patients (with allergic symptoms of any severity provoked by the consumption of peach) will be divided into two groups: the first group showing oral allergy syndrome (OAS), the second group showing systemic symptoms of different severity, up to anaphylaxis.

All the patients will be submitted to: complete clinical investigation; skin prick test with a panel of common food/inhalant commercial extracts; skin tests by the "prick + prick" method with fresh fruits and vegetables; skin prick test with purified peach LTP (Pru p 3) The sera of the patients will be used for: immunoblotting with peach extract and immunoblotting inhibition with purified natural Pru p 3 and, if possible, recombinant Pru p 3, Pru p 1 and Pru p 4, using a pool of selected sera; CAP system with a predetermined panel of fruit and vegetable allergens; CAP system with recombinant allergens of peach and birch pollen: Pru p 3, Pru p 1 and Pru p 4 for peach, Bet v 1, Bet v 2 and Bet v 4 for birch pollen. Finally, a statistical analysis will be carried out in order to verify if the two groups of patients will show significant differences in the allergens recognized. The results of this study will be a property of the Unit of Allergology and Immunology as stated by DM 17/2004 and will be presented as written publication or oral presentation at National and/or International Congresses of Allergy and Immunology, quoting the PHADIA company


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Peach allergic subjects at major risk of anaphylaxis

Inclusion Criteria:

  • female and male;
  • pts with 18 e 80 years old;
  • signature of the informed consent form;
  • CAP/RAST positive for peach;
  • clinical manifestation of peach allergy

Exclusion Criteria:

  • pregnancy;
  • current antihistamine therapy;
  • subjects that do not give consent to the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00715156

Niguarda Hospital
Milano, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
Principal Investigator: Elide A Patorello, MD Niguarda Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Niguarda Hospital Identifier: NCT00715156     History of Changes
Other Study ID Numbers: Peach allergy
Study First Received: July 14, 2008
Last Updated: February 20, 2012

Keywords provided by Niguarda Hospital:
allergy, peach, birch
recombinants allergens diagnosis
systemic reactions
subjects with severe reaction to other fruits

Additional relevant MeSH terms:
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate processed this record on September 21, 2017