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Efficacy of Local Food Extracts at Different Storage Times

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 3 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02774629
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mahidol University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nualanong Visitsunthorn, Prof
Principal Investigator Affiliation Mahidol University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Thailand
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Additional Details

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

Contact a Trial Team

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International Sites

Siriraj hospital, Bangkok, Thailand

Status

Recruiting

Address

Siriraj hospital

Bangkok, , 10700

Site Contact

Nualanong Visitsunthorn, Prof

nualanongv@yahoo.com

024197000 #95941

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