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Role of Recombinants in Peach Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT00715156
First received: July 14, 2008
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

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

Blood sample
Enrollment: 148
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: October 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT00715156     History of Changes
Other Study ID Numbers: Peach allergy
Study First Received: July 14, 2008
Last Updated: February 20, 2012
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

ClinicalTrials.gov processed this record on March 03, 2015