The Utility of Serum Tryptase in the Diagnosis of Shrimp-... | NCT01619605

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

NCT01619605

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jun 15, 2012Estimated

Enrollment

39Actual

Phase

Not Applicable

Conditions

Food (Shrimp) Allergy

Interventions

shrimp challenge

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

May 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 12, 2012

First Posted Date

Jun 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2012

Last Update Posted Date

Jun 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shrim	Experimental		Procedure: shrimp challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Serum tryptases		baseline and 60 minutes after the onset of symptoms

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Orathai Piboonpocanun, Assoc.Prof.	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric allergy clinic, Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkoknoi	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D000707	Anaphylaxis

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided