An observational study in Food Allergy and Respiratory Allergy, sponsored by Niguarda Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-03-07.
Sponsored by Niguarda Hospital · Observational
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 100 is below the median of 115 across 479 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Niguarda Hospital is the lead sponsor of 66 studies on the registry; 28 are open to participants now.
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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
Exclusion Criteria:
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 and IgE positive to dust mites, asymptomatic for shrimp or other shellfish and circulating IgE positive for shrimp
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
Time frame: One day
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.
Time frame: 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
Time frame: Two days
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Niguarda Hospital