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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02774629
Other study ID # 619/2556(EC3)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date August 31, 2019

Study information

Verified date March 2019
Source Mahidol University
Contact Nualanong Visitsunthorn, Professor
Phone 024197000
Email nualanongv@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Local lyophylized food extracts are available useful in skin prick test and atopy patch test to confirm food allergy. However, the investigators want to know the duration that the investigators can keep the extracts for the usage in this purpose.


Description:

Food allergy incidence increases world wide. The diagnosis mostly depends on history. Skin prick test and atopic patch test are useful in finding the causative foods in some cases. The local food extracts have been shown to be at least as effective as commercial ones. From previous study the investigators keep the extract at 2-8 degree Celsius for 1-3 months for the usage. The investigators want to evaluate the duration that the extracts are still useful in diagnosis food allergy


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- Positive skin prick test to one of the food (milk, egg, soy, wheat, seafood)

Exclusion Criteria:

- Chronic diseases such as heart disease, liver, renal and severe sepsis

- Severe allergic symptoms such as anaphylaxis

- Extensive skin rashes

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
prick and patch test
The cases are pricked and patched with local food allergen extract at different storage times (0, 3 and 6 months after preparation)

Locations

Country Name City State
Thailand Siriraj hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean wheal diameter of skin prick test The skin prick tests are performed with local prepared food allergen at keeping time of 0, 3 and 6 months after the preparation. 2 years
Secondary Result of atopy patch test atopy patch tests are performed with local prepared food allergen at keeping time of 0, 3 and 6 months after the preparation. 2 years
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