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
About this trial
This is an interventional diagnostic trial for Food (Shrimp) Allergy focused on measuring tryptases, anaphylaxis, shrimp allergy
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
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
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
Learn more about this trial
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
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