Role of Recombinants in Peach Allergy

NCT ID: NCT00715156

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-11-30

Brief 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

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

Conditions

Food Allergy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

A

Subjects with mild (S1) reaction to peach fruit

No interventions assigned to this group

B

Subjects with severe reaction to peach fruit

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Niguarda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elide A Patorello, MD

Role: PRINCIPAL_INVESTIGATOR

Niguarda Hospital

Locations

Niguarda Hospital

Milan, Italy, Italy

Countries

Italy

References

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 severe symptoms when also presenting IgE antibodies to Pru p 1 and Pru p 4. Int Arch Allergy Immunol. 2011;156(4):362-72. doi: 10.1159/000324440. Epub 2011 Aug 9.

Reference Type: RESULT

PMID: 21829031 (View on PubMed)

Mascheri A, Farioli L, Pravettoni V, Piantanida M, Stafylaraki C, Scibilia J, Mirone C, Preziosi D, Nichelatti M, Pastorello EA. Hypersensitivity to Tomato (Lycopersicon esculentum) in Peach-Allergic Patients: rPrup 3 and rPrup 1 Are Predictive of Symptom Severity. J Investig Allergol Clin Immunol. 2015;25(3):183-9.

Reference Type: DERIVED

PMID: 26182684 (View on PubMed)

Other Identifiers

Peach allergy

Identifier Type: -

Identifier Source: org_study_id