Food AllergyNCT00715156
Role of Recombinants in Peach Allergy
An observational study of Food Allergy, run by Niguarda Hospital at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Food Allergy
- How many people
- 148 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Peach allergic subjects at major risk of anaphylaxis
Who may be able to join
- 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
Who cannot join
- pregnancy;
- current antihistamine therapy;
- subjects that do not give consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Classification of Different Forms of Peach Allergy and the Role of Recombinant Allergens in the Diagnosis
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
Read the 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
- Keywords
- allergy, peach, birch, recombinants allergens diagnosis, OAS, LTP, systemic reactions, subjects with severe reaction to other fruits
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Subjects with mild (S1) reaction to peach fruit | |
| B | Subjects with severe reaction to peach fruit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elide A Patorello, MD, Principal investigator, Niguarda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715156
- Sponsor's protocol ID
- Peach allergy
- Status last verified
- Feb 2012
- First submitted
- 14 Jul 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21829031Mascheri 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.
PubMed 26182684
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Different Forms of Peach Allergy and the Role of Recombinant Allergens in the Diagnosis
- ClinicalTrials.gov ID
- NCT00715156
- Acronym / sponsor ID
- Peach allergy
- Conditions
- Food Allergy
- Keywords
- allergy, peach, birch, recombinants allergens diagnosis, OAS, LTP, systemic reactions, subjects with severe reaction to other fruits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Subjects with mild (S1) reaction to peach fruit |
| B | – | –Subjects with severe reaction to peach fruit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Peach allergic subjects at major risk of anaphylaxis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy;
- current antihistamine therapy;
- subjects that do not give consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Evaluate whether the above recombinants allergens could help identifying subjects with severe reaction to other fruits
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Results publication: PubMed 21829031Pastorello 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.
- Derived from this study: PubMed 26182684Mascheri 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.
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elide A Patorello, MD principal investigator
Niguarda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.