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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03645629
Other study ID # 619/2556 (EC 3)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date July 31, 2019

Study information

Verified date August 2019
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
skin test with food at different storage times
Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results

Locations

Country Name City State
Thailand Siriraj Hospital. Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 month
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