Food AllergyNCT02774629
Efficacy of Local Food Extracts at Different Storage Times
An observational study of Food Allergy, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- prick and patch test
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2017to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Food allergy cases aged 3-18 years old.
Who may be able to join
- Positive skin prick test to one of the food (milk, egg, soy, wheat, seafood)
Who cannot join
- Chronic diseases such as heart disease, liver, renal and severe sepsis
- Severe allergic symptoms such as anaphylaxis
- Extensive skin rashes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj hospital
Bangkok, 10700
Nualanong Visitsunthorn, Prof, 024197000 ext. 95941, nualanongv@yahoo.com
Orathai Jirapongsananurak, Prof, 024197000 ext. 95942, jirapongo@yahoo.com
About this study
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)
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.
Read the detailed 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
- Conditions
- Food Allergy
- Being tested
- prick and patch test
- Keywords
- food allergy, skin prick test, atopy patch test
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, Prof, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774629
- Sponsor's protocol ID
- 619/2556(EC3)
- Status last verified
- Mar 2019
- First submitted
- 11 May 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02774629
- Acronym / sponsor ID
- 619/2556(EC3)
- Conditions
- Food Allergy
- Keywords
- food allergy, skin prick test, atopy patch test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Food allergy cases aged 3-18 years old.
Key inclusion criteria (1 listed)
- Positive skin prick test to one of the food (milk, egg, soy, wheat, seafood)
Key exclusion criteria (4 listed)
- Chronic diseases such as heart disease, liver, renal and severe sepsis
- Severe allergic symptoms such as anaphylaxis
- Extensive skin rashes
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prick and patch testThe cases are pricked and patched with local food allergen extract at different storage times (0, 3 and 6 months after preparation) | Other | – |
Primary outcome
Mean wheal diameter of skin prick test
Time frame: 2 years
The skin prick tests are performed with local prepared food allergen at keeping time of 0, 3 and 6 months after the preparation.
1 secondary outcome
Result of atopy patch test
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nualanong Visitsunthorn, Prof principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nualanong Visitsunthorn, Professor (024197000 ext. 95941, nualanongv@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean wheal diameter of skin prick test (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.