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

Primary Purpose

Food (Shrimp) Allergy

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
shrimp challenge
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Food (Shrimp) Allergy focused on measuring tryptases, anaphylaxis, shrimp allergy

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shrim

Arm Description

Outcomes

Primary Outcome Measures

Change of Serum tryptases

Secondary Outcome Measures

Full Information

First Posted
June 12, 2012
Last Updated
June 14, 2012
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01619605
Brief Title
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
Official Title
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food (Shrimp) Allergy
Keywords
tryptases, anaphylaxis, shrimp allergy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shrim
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
shrimp challenge
Other Intervention Name(s)
open food challenge
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of Serum tryptases
Time Frame
baseline and 60 minutes after the onset of symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orathai Piboonpocanun, Assoc.Prof.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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

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