Crustacean Allergy and Dust Mites Sensitization

NCT01634737 | Completed

• 1 other identifier: 235_09/2010
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Respiratory Allergy

Keywords

shellfish; tropomyosin; mites; food allergy

Outcome Measures

Primary Outcomes (1)

• 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

  One day

Secondary Outcomes (2)

• Determination of specific IgE reactivity profile of each individual patient by immunoblotting

  One day

• Oral provocation test in double-blind placebo-controlled

  Two days

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

AO Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for in vitro investigations

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: October 1, 2012
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

IT (1)