Food AllergyNCT01634737
Crustacean Allergy and Dust Mites Sensitization
An observational study of Food Allergy and Respiratory Allergy, run by Niguarda Hospital at 1 site in Italy.
Trial summary
This study evaluates the diagnostic efficacy of CAP System (capsulated hydrophilic carrier polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects allergic to shrimp with CAP positive subjects allergic to mites, crustaceans asymptomatic but with a positive CAP to shrimp, to identify… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Food Allergy, Respiratory Allergy
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2010to Oct 2012
- 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: Will be selected a group of patients (group A) consisted of 50 subjects with a history of allergic reactions to shellfish, both slight localized to the oral cavity than severe systemic, these patients will show positive IgE to the extract of whole shrimp. In this group may also be included subjects with symptoms and circulating IgE positive for dust mites, both symptomatic and asymptomatic
Who may be able to join
- males and females aged between 18 and 80 years;
- Patients with clinical manifestations have been discovered and documented allergy to shrimp and / or mite in which both demonstrated IgE-mediated mechanism (CAP System for shrimp and / or mite positive);
- patients with questionable symptoms to shellfish are tested for unleashing double-blind placebo-controlled trial with shrimp and when clinical manifestations are enrolled;
- all patients with these characteristics will necessarily have to sign the informed consent for inclusion in the study.
Who cannot join
- Women who are pregnant;
- patients chronically treated with antihistamines or steroids;
- those who deny consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crustacean Allergy and Sensitization to Dust Mites in Patients With Respiratory Allergy: Clinical Study and Analysis of Common and Peculiar Allergens
This study evaluates the diagnostic efficacy of CAP System (capsulated hydrophilic carrier polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects allergic to shrimp with CAP positive subjects allergic to mites, crustaceans asymptomatic but with a positive CAP to shrimp, to identify those at greatest risk of food reactions.
Read the detailed description
Most epidemiological data related to allergy to shellfish come from the USA, where 2.5% of the adult population is subject to an allergy to shellfish, which is also the leading cause of anaphylaxis in adults in these areas. This allergy affects also the European adult population, so that the crustaceans were included in the European Directive 2003/89/EC on the labeling requirement to indicate any allergenic ingredients (listed in Annex 3 a) used in the production of a food and present, although in other form, in the finished product. The allergen mainly involved in allergic reactions to shellfish food is the tropomyosin protein of PM of about 34-36 kDa, isolated for the first time in the shrimp (Pen to 1), involved in the mechanisms of muscle activation and identified in the muscle fiber of many crustaceans (Pen i 1, Cha f 1, Cra c 1, Hom a 1, v 1 Lit, Pan s 1, Pen m 1) and molluscs (Hel as 1, d 1 Hal, Cra g 1, Oct 1 st, Tod p 1). The tropomyosins, identified in many other invertebrates, such as dust mites and cockroaches, seem to be cross-reactive with each other, suggesting the role of allergens inside of the Invertebrates. In those circumstances, the positivity of specific IgE for the crustaceans can thus be determined also by sensitization to tropomyosin even for simple cross-reactivity with tropomyosin of the mites, which represents a minor allergen Der known as p10.
- Conditions
- Food Allergy, Respiratory Allergy
- Keywords
- shellfish, tropomyosin, mites, food allergy
- Medical subject headings
- Food 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 |
|---|---|---|
| Patients with shellfish allergy | Patients with symptoms of allergy to shellfish (OAS-Oral allergy syndrome and/or systemic symptoms) and circulating IgE positive for the extract of shrimp (> 0.10 kU/L) | |
| Patients with respiratory allergy | Patients with respiratory allergy and IgE positive to dust mites, asymptomatic for shrimp or other shellfish and circulating IgE positive for shrimp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the ability of the CAP System for recombinant tropomyosin in identifying those most at risk of food reactions
Will be carried out the assay of specific IgE to the extract of shrimp and other shellfish and dust mites by the CAP System.On the same blood sample will be also made for the CAP recombinant major allergens Der p1,Der p2 and tropomyosin recombinant mite Der p 10 and the recombinant shrimp tropomyosin Pen a 1.The test consists of a reaction between allergens covalently bound to a solid phase(ImmunoCAP) and the specific IgE in the serum.This reaction is highlighted by the use of anti-IgE conjugated with an enzyme and the subsequent addition of a reagent of development
Measured: One day
Secondary outcomes (2)
Determination of specific IgE reactivity profile of each individual patient by immunoblotting
After separation by SDS-PAGE (Sodium Dodecyl Sulphate - PolyAcrylamide Gel Electrophoresis) proteins are transferred thanks to an electric field on a nitrocellulose membrane, which will subsequently be cut into strips. Each strip will be incubated with the serum of a patient; the binding of specific IgE to allergenic proteins will be detected by anti-human IgE antibodies radiolabeled with I125. Using autoradiographic films will be highlighted so the pattern corresponding to the specific IgE-binding allergenic profile recognized by each patient studied and related to both mite and shrimp.
Measured: One day
Oral provocation test in double-blind placebo-controlled
Patients with a doubtful allergic reaction to shrimp will be tested for oral provocation against placebo with shrimp cooked according to the method described in 1988 by Lherer
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634737
- Sponsor's protocol ID
- 235_09/2010
- Status last verified
- Mar 2014
- First submitted
- 3 Jul 2012
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crustacean Allergy and Sensitization to Dust Mites in Patients With Respiratory Allergy: Clinical Study and Analysis of Common and Peculiar Allergens
- ClinicalTrials.gov ID
- NCT01634737
- Acronym / sponsor ID
- 235_09/2010
- Conditions
- Food Allergy, Respiratory Allergy
- Keywords
- shellfish, tropomyosin, mites, food allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Jul 2012 (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 evaluates the diagnostic efficacy of CAP System (capsulated hydrophilic carrier polymer) for recombinant tropomyosin from shrimp extract in discriminating between subjects allergic to shrimp with CAP positive subjects allergic to mites, crustaceans asymptomatic but with a positive CAP to shrimp, to identify those at greatest risk of food reactions.
Detailed description
Most epidemiological data related to allergy to shellfish come from the USA, where 2.5% of the adult population is subject to an allergy to shellfish, which is also the leading cause of anaphylaxis in adults in these areas. This allergy affects also the European adult population, so that the crustaceans were included in the European Directive 2003/89/EC on the labeling requirement to indicate any allergenic ingredients (listed in Annex 3 a) used in the production of a food and present, although in other form, in the finished product. The allergen mainly involved in allergic reactions to shellfish food is the tropomyosin protein of PM of about 34-36 kDa, isolated for the first time in the shrimp (Pen to 1), involved in the mechanisms of muscle activation and identified in the muscle fiber of many crustaceans (Pen i 1, Cha f 1, Cra c 1, Hom a 1, v 1 Lit, Pan s 1, Pen m 1) and molluscs (Hel as 1, d 1 Hal, Cra g 1, Oct 1 st, Tod p 1). The tropomyosins, identified in many other invertebrates, such as dust mites and cockroaches, seem to be cross-reactive with each other, suggesting the role of allergens inside of the Invertebrates. In those circumstances, the positivity of specific IgE for the crustaceans can thus be determined also by sensitization to tropomyosin even for simple cross-reactivity with tropomyosin of the mites, which represents a minor allergen Der known as p10.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with shellfish allergy | – | –Patients with symptoms of allergy to shellfish (OAS-Oral allergy syndrome and/or systemic symptoms) and circulating IgE positive for the extract of shrimp (> 0.10 kU/L) |
| Patients with respiratory allergy | – | –Patients with respiratory allergy and IgE positive to dust mites, asymptomatic for shrimp or other shellfish and circulating IgE positive for shrimp |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Will be selected a group of patients (group A) consisted of 50 subjects with a history of allergic reactions to shellfish, both slight localized to the oral cavity than severe systemic, these patients will show positive IgE to the extract of whole shrimp. In this group may also be included subjects with symptoms and circulating IgE positive for dust mites, both symptomatic and asymptomatic
Key inclusion criteria (4 listed)
- males and females aged between 18 and 80 years;
- Patients with clinical manifestations have been discovered and documented allergy to shrimp and / or mite in which both demonstrated IgE-mediated mechanism (CAP System for shrimp and / or mite positive);
- patients with questionable symptoms to shellfish are tested for unleashing double-blind placebo-controlled trial with shrimp and when clinical manifestations are enrolled;
- all patients with these characteristics will necessarily have to sign the informed consent for inclusion in the study.
Key exclusion criteria (3 listed)
- Women who are pregnant;
- patients chronically treated with antihistamines or steroids;
- those who deny consent to participate.
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 the ability of the CAP System for recombinant tropomyosin in identifying those most at risk of food reactions
Time frame: One day
Will be carried out the assay of specific IgE to the extract of shrimp and other shellfish and dust mites by the CAP System.On the same blood sample will be also made for the CAP recombinant major allergens Der p1,Der p2 and tropomyosin recombinant mite Der p 10 and the recombinant shrimp tropomyosin Pen a 1.The test consists of a reaction between allergens covalently bound to a solid phase(ImmunoCAP) and the specific IgE in the serum.This reaction is highlighted by the use of anti-IgE conjugated with an enzyme and the subsequent addition of a reagent of development
2 secondary outcomes
Determination of specific IgE reactivity profile of each individual patient by immunoblotting
Time frame: One day
Oral provocation test in double-blind placebo-controlled
Time frame: Two days
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 7 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Respiratory 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 4 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 7 Mar 2014. 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 the ability of the CAP System for recombinant tropomyosin in identifying those most at risk of food reactions (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2014; AzTrials last refreshed its copy on 1 Nov 2026.