Role of Recombinants in Peach Allergy

Food Allergy Clinical Trial

Official title:

Classification of Different Forms of Peach Allergy and the Role of Recombinant Allergens in the Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715156
• Other study ID #: Peach allergy
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: February 20, 2012
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2012
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Italy	Niguarda Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Pastorello EA, Farioli L, Pravettoni V, Scibilia J, Mascheri A, Borgonovo L, Piantanida M, Primavesi L, Stafylaraki C, Pasqualetti S, Schroeder J, Nichelatti M, Marocchi A. Pru p 3-sensitised Italian peach-allergic patients are less likely to develop seve — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year	Yes
Secondary	Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits		1 year	Yes