Skin Prick Test for the Diagnosis of Food Allergy- a Comp... | NCT01508299

Studies
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food

NCT01508299

Sponsor

Meir Medical Center

Status

Completed

Last Update Posted

Oct 7, 2015Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Food Allergy

Interventions

skin test

Countries

Israel

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

Oct 2015

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

Apr 2012

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 10, 2012

First Posted Date

Jan 11, 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

Oct 6, 2015

Last Update Posted Date

Oct 7, 2015Estimated

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

Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal and reproduce false negative results (no allergy) in patients with history highly suggestive of allergic reaction. The aim of this study is to compare the reproducibility of different commercial extracts and raw food in patients with convincing history of acute allergic symptoms related to food .

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
raw food skin test	Experimental	skin test with the suspected raw food	Procedure: skin test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skin test	Procedure	skin test with the Suspected raw food	raw food skin test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between the results of skin test with commercial extracts and raw food		immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected immediate allergic reaction to food

Exclusion Criteria:none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allergy and clinical immunology unit , Meir hospital		Kfar Saba	Israel	44281	Israel

Condition Browse Module

MeSH Terms

ID	Term
D005512	Food Hypersensitivity

Ancestor Terms

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012882	Skin Tests

Ancestor Terms

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided