NCT02774629

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

May 11, 2016

Last Update Submit

March 13, 2019

Conditions

Food Allergy

Keywords

food allergyskin prick testatopy patch test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Result of atopy patch test

    2 years

Interventions

prick and patch testOTHER

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

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Food allergy cases aged 3-18 years old.

You may qualify if:

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

You may not qualify if:

  • Chronic diseases such as heart disease, liver, renal and severe sepsis
  • Severe allergic symptoms such as anaphylaxis
  • Extensive skin rashes
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

PuncturesPatch Tests

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, OperativeSkin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Nualanong Visitsunthorn, Prof

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nualanong Visitsunthorn, Professor

CONTACT

024197000nualanongv@yahoo.com

Orathai Jirapongsananurak, Prof

CONTACT

024197000jirapongo@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 17, 2016

Study Start

January 1, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)