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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01619605
First received: June 12, 2012
Last updated: June 14, 2012
Last verified: June 2012
  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: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01619605     History of Changes
Other Study ID Numbers: 669/2551(EC4)
Study First Received: June 12, 2012
Last Updated: June 14, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
tryptases
anaphylaxis
shrimp allergy

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

ClinicalTrials.gov processed this record on July 23, 2014