The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
|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|
- Change of Serum tryptases [ Time Frame: baseline and 60 minutes after the onset of symptoms ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619605
|Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator:||Orathai Piboonpocanun, Assoc.Prof.||Mahidol University|