Role of Recombinants in Peach Allergy
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ClinicalTrials.gov Identifier: NCT00715156 |
Recruitment Status :
Completed
First Posted : July 15, 2008
Last Update Posted : February 22, 2012
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Condition or disease |
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Food Allergy |
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
Study Type : | Observational |
Actual Enrollment : | 148 participants |
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 |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | November 2010 |
Group/Cohort |
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A
Subjects with mild (S1) reaction to peach fruit
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B
Subjects with severe reaction to peach fruit
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- 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 ]
- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715156
Italy | |
Niguarda Hospital | |
Milano, Italy, 20162 |
Principal Investigator: | Elide A Patorello, MD | Niguarda Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Niguarda Hospital |
ClinicalTrials.gov Identifier: | NCT00715156 |
Other Study ID Numbers: |
Peach allergy |
First Posted: | July 15, 2008 Key Record Dates |
Last Update Posted: | February 22, 2012 |
Last Verified: | February 2012 |
allergy, peach, birch recombinants allergens diagnosis OAS |
LTP systemic reactions subjects with severe reaction to other fruits |
Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |