Back to resultsSkin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food
Primary Purpose
Food Allergy
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
skin test
Sponsored by
About this trial
This is an interventional diagnostic trial for Food Allergy focused on measuring skin test, raw food, commercial extract
Eligibility Criteria
Inclusion Criteria:
- Suspected immediate allergic reaction to food
Exclusion Criteria:none
Sites / Locations
- Allergy and clinical immunology unit , Meir hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
raw food skin test
Arm Description
skin test with the suspected raw food
Outcomes
Primary Outcome Measures
correlation between the results of skin test with commercial extracts and raw food
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01508299
Brief Title
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food
Official Title
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
skin test, raw food, commercial extract
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
raw food skin test
Arm Type
Experimental
Arm Description
skin test with the suspected raw food
Intervention Type
Procedure
Intervention Name(s)
skin test
Intervention Description
skin test with the Suspected raw food
Primary Outcome Measure Information:
Title
correlation between the results of skin test with commercial extracts and raw food
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected immediate allergic reaction to food
Exclusion Criteria:none
Facility Information:
Facility Name
Allergy and clinical immunology unit , Meir hospital
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
12. IPD Sharing Statement
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Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food
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