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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01619605
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : June 15, 2012
Information provided by (Responsible Party):
Mahidol University

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

Condition or disease Intervention/treatment Phase
Food (Shrimp) Allergy Procedure: shrimp challenge Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
Study Start Date : June 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anaphylaxis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Shrim 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
Other Name: open food challenge

Primary Outcome Measures :
  1. Change of Serum tryptases [ Time Frame: baseline and 60 minutes after the onset of symptoms ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01619605

Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Orathai Piboonpocanun, Assoc.Prof. Mahidol University

Responsible Party: Mahidol University Identifier: NCT01619605     History of Changes
Other Study ID Numbers: 669/2551(EC4)
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012

Keywords provided by Mahidol University:
shrimp allergy

Additional relevant MeSH terms:
Hypersensitivity, Immediate
Immune System Diseases