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

Food (Shrimp) Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619605
• Other study ID #: 669/2551(EC4)
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: June 14, 2012
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2012
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 ß-blocking agents

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anaphylaxis
• Food (Shrimp) Allergy

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Thailand	Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Serum tryptases		baseline and 60 minutes after the onset of symptoms	Yes