Role of Recombinants in Peach Allergy - Full Text View

Sponsored by:	Niguarda Hospital
Information provided by:	Niguarda Hospital
ClinicalTrials.gov Identifier:	NCT00715156

Purpose

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

Condition
Food Allergy

MedlinePlus related topics: Allergy Food Allergy

U.S. FDA Resources

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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood sample

Estimated Enrollment:	140
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
A Subjects with mild (S1) reaction to peach fruit
B 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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Peach allergic subjects at major risk of anaphylaxis

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715156

Contacts

Contact: Elide A Pastorello, MD

+39026444 ext 4414

elide.pastorello@ospedaleniguarda.it

Locations

Italy
Niguarda Hospital	Recruiting
Milano, Italy, 20162
Contact: Elide A Pastorello, MD +39026444 ext 4414 elide.pastorello@ospedaleniguarda.it

Sponsors and Collaborators

Niguarda Hospital

Investigators

Principal Investigator:

Elide A Patorello, MD

Niguarda Hospital

More Information

Responsible Party:	Niguarda Hospital ( Elide Anna Pastorello, MD )
Study ID Numbers:	Peach allergy
Study First Received:	July 14, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00715156
Health Authority:	Italy: Ethics Committee

Keywords provided by Niguarda Hospital:

allergy, peach, birch
recombinants allergens diagnosis
OAS

LTP
systemic reactions
subjects with severe reaction to other fruits

Study placed in the following topic categories:

Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009