The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis

NCT ID: NCT01619605

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.

Detailed Description

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The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease.

Currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations.

Therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed.

In addition, shrimp is the major cause of seafood anaphylaxis among Thai children.

Conditions

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Food (Shrimp) Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Shrim

Group Type EXPERIMENTAL

shrimp challenge

Intervention Type PROCEDURE

Patients with history of shrimp allergy and positive skin tests to shrimp were recruited for shrimp challenges After shrimp challenges, patients with anaphylaxis defined as anaphylaxis group, patients with mild reactions defined as mild reaction group, and patients without symptom defined as control group

Interventions

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shrimp challenge

Patients with history of shrimp allergy and positive skin tests to shrimp were recruited for shrimp challenges After shrimp challenges, patients with anaphylaxis defined as anaphylaxis group, patients with mild reactions defined as mild reaction group, and patients without symptom defined as control group

Intervention Type PROCEDURE

Other Intervention Names

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open food challenge

Eligibility Criteria

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Inclusion Criteria

* a history of shrimp allergy

Exclusion Criteria

* severe anaphylactic reaction from seafood
* pregnancy
* underlying diseases such as cardiovascular, hepatobiliary, and renal diseases
* on systemic corticosteroid or β-blocking agents
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Orathai Piboonpocanun, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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669/2551(EC4)

Identifier Type: -

Identifier Source: org_study_id

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