Back to resultsEfficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time
Primary Purpose
Food Allergy
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
skin test with food at different storage times
Sponsored by
About this trial
This is an interventional diagnostic trial for Food Allergy
Eligibility Criteria
Inclusion Criteria:
- mild to moderately severe food allergy patients
- At least positive skin test to one kind of common food (commercial extract)
- Stop antihistamine or corticosteroid (if more than 20mg/day) for at least 7 days
Exclusion Criteria:
- Dermographism
- Severe systemic disease such as autoimmune disease, immune deficiency, malignancy
- Severe dermatitis or large area involment
- pregnancy
Sites / Locations
- Siriraj Hospital. Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Food skin tests at 0 month
Food skin tests at 3 month
Food skin tests at 6 month
Arm Description
the skin test results of food extract at time 0 months after preparation
the skin test results of food extract at time 3 months after preparation
the skin test results of food extract at time 6 months after preparation
Outcomes
Primary Outcome Measures
skin test result of lyophilized foods at 6 months after preparation
Perform skin prick test and atopy patch test the patients with lyophilized foods at 0, 3 and 6 months after preparation and compare the results at 6 months to 0 and 3 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03645629
Brief Title
Efficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time
Official Title
Comparison of Skin Prick Tests and Atopy Patch Test Results of Lyophilized Food Extracts at Different Storage Time (0, 3 and 6 Months) After Preparation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison the result of skin prick tests and atopy patch test of lyophilized food extracts at different storage time (0, 3 and 6 months) after preparation
Detailed Description
Skin prick test were performed with lyophilized food extracts (cow milk, egg white, egg yolk, wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation.
Atopy patch test were performed with lyophilized food extracts (cow milk, egg white, egg yolk, wheat, soy and shrimp) at different storage time (0, 3 and 6 months) after preparation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Perform skin prick test and atopy patch test of lyophilized foods (cow milk, egg white, egg yolk, wheat, soy and shrimp) stored at different time; 0, 3 and 6 months after preparation.
Then compare the results.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food skin tests at 0 month
Arm Type
Active Comparator
Arm Description
the skin test results of food extract at time 0 months after preparation
Arm Title
Food skin tests at 3 month
Arm Type
Active Comparator
Arm Description
the skin test results of food extract at time 3 months after preparation
Arm Title
Food skin tests at 6 month
Arm Type
Active Comparator
Arm Description
the skin test results of food extract at time 6 months after preparation
Intervention Type
Diagnostic Test
Intervention Name(s)
skin test with food at different storage times
Intervention Description
Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results
Primary Outcome Measure Information:
Title
skin test result of lyophilized foods at 6 months after preparation
Description
Perform skin prick test and atopy patch test the patients with lyophilized foods at 0, 3 and 6 months after preparation and compare the results at 6 months to 0 and 3 months.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild to moderately severe food allergy patients
At least positive skin test to one kind of common food (commercial extract)
Stop antihistamine or corticosteroid (if more than 20mg/day) for at least 7 days
Exclusion Criteria:
Dermographism
Severe systemic disease such as autoimmune disease, immune deficiency, malignancy
Severe dermatitis or large area involment
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nualanong Visitsunthorn, MD
Organizational Affiliation
Department of Pediatrics, Siriraj hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital. Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Publication
Learn more about this trial
Efficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time
We'll reach out to this number within 24 hrs