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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
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital

Study Description
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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

Condition or disease
Food 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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Groups and Cohorts
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Group/Cohort
A
Subjects with mild (S1) reaction to peach fruit
B
Subjects with severe reaction to peach fruit


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria
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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
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
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Information from the National Library of Medicine

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


Locations
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Italy
Niguarda Hospital
Milano, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
Investigators
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Principal Investigator: Elide A Patorello, MD Niguarda Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Niguarda Hospital:
allergy, peach, birch
recombinants allergens diagnosis
OAS
 LTP
systemic reactions
subjects with severe reaction to other fruits
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate