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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619605
First Posted: June 14, 2012
Last Update Posted: June 15, 2012
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.
Information provided by (Responsible Party):
Mahidol University
  Purpose
The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.

Condition Intervention
Food (Shrimp) Allergy Procedure: shrimp challenge

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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

Enrollment: 39
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01619605


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

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01619605     History of Changes
Other Study ID Numbers: 669/2551(EC4)
First Submitted: June 12, 2012
First Posted: June 14, 2012
Last Update Posted: June 15, 2012
Last Verified: June 2012

Keywords provided by Mahidol University:
tryptases
anaphylaxis
shrimp allergy

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases