Crustacean Allergy and Dust Mites Sensitization

NCT ID: NCT01634737

Last Updated: 2014-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-10-31

Brief 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 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.

Conditions

Food Allergy; Respiratory Allergy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Women who are pregnant;
• patients chronically treated with antihistamines or steroids;
• those who deny consent to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Niguarda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AO Ospedale Niguarda Ca' Granda

Milan, , Italy

Countries

Italy

Other Identifiers

235_09/2010

Identifier Type: -

Identifier Source: org_study_id