Efficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time

NCT ID: NCT03645629

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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

Conditions

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Food Allergy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Food skin tests at 0 month

the skin test results of food extract at time 0 months after preparation

Group Type ACTIVE_COMPARATOR

skin test with food at different storage times

Intervention Type DIAGNOSTIC_TEST

Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results

Food skin tests at 3 month

the skin test results of food extract at time 3 months after preparation

Group Type ACTIVE_COMPARATOR

skin test with food at different storage times

Intervention Type DIAGNOSTIC_TEST

Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results

Food skin tests at 6 month

the skin test results of food extract at time 6 months after preparation

Group Type ACTIVE_COMPARATOR

skin test with food at different storage times

Intervention Type DIAGNOSTIC_TEST

Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Nualanong Visitsunthorn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nualanong Visitsunthorn, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Siriraj hospital, Mahidol University

Locations

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Siriraj Hospital. Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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619/2556 (EC 3)

Identifier Type: -

Identifier Source: org_study_id

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