Skip to main content
OpenTrials
Completed

NCT Number: NCT01619605

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Food (Shrimp) Allergy Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

shrimp challenge

Procedure

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: open food challenge

Primary outcomes

  1. Change of Serum tryptases

    Time frame: baseline and 60 minutes after the onset of symptoms

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 14, 2012
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.