- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619605
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shrim
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Serum tryptases
Time Frame: baseline and 60 minutes after the onset of symptoms
|
baseline and 60 minutes after the onset of symptoms
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Orathai Piboonpocanun, Assoc.Prof., Mahidol University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 669/2551(EC4)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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