Efficacy of Local Food Extracts at Different Storage Times

Food Allergy Clinical Trial

Official title:

Efficacy of Local Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Times (0, 3 and 6 Months)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02774629
• Other study ID #: 619/2556(EC3)
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity

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