Food AllergyNCT03645629
Efficacy of Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Time
A study testing skin test with food at different storage times in people with Food Allergy, run by Mahidol University at 1 site in Thailand.
Trial summary
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 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?
- skin test with food at different storage times
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2018to 31 Jul 2019
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- Dermographism
- Severe systemic disease such as autoimmune disease, immune deficiency, malignancy
- Severe dermatitis or large area involment
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Skin Prick Tests and Atopy Patch Test Results of Lyophilized Food Extracts at Different Storage Time (0, 3 and 6 Months) After Preparation
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
Read the detailed description
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
- Food Allergy
- Being tested
- skin test with food at different storage times
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin test with food at different storage timesDiagnostic test
Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results
| Study group | Role | What they receive |
|---|---|---|
| Food skin tests at 0 month | Active comparator | the skin test results of food extract at time 0 months after preparation Receives: Diagnostic Test: skin test with food at different storage times |
| Food skin tests at 3 month | Active comparator | the skin test results of food extract at time 3 months after preparation Receives: Diagnostic Test: skin test with food at different storage times |
| Food skin tests at 6 month | Active comparator | the skin test results of food extract at time 6 months after preparation Receives: Diagnostic Test: skin test with food at different storage times |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin test result of lyophilized foods at 6 months after preparation
Perform skin prick test and atopy patch test the patients with lyophilized foods at 0, 3 and 6 months after preparation and compare the results at 6 months to 0 and 3 months.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2019
- Study completion31 Jul 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, MD, Principal investigator, Department of Pediatrics, Siriraj hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645629
- Sponsor's protocol ID
- 619/2556 (EC 3)
- Status last verified
- Aug 2019
- First submitted
- 17 Aug 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Prick Tests and Atopy Patch Test Results of Lyophilized Food Extracts at Different Storage Time (0, 3 and 6 Months) After Preparation
- ClinicalTrials.gov ID
- NCT03645629
- Acronym / sponsor ID
- 619/2556 (EC 3)
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- 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.
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
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Food skin tests at 0 month | Active comparator | Diagnostic Test: skin test with food at different storage timesthe skin test results of food extract at time 0 months after preparation |
| Food skin tests at 3 month | Active comparator | Diagnostic Test: skin test with food at different storage timesthe skin test results of food extract at time 3 months after preparation |
| Food skin tests at 6 month | Active comparator | Diagnostic Test: skin test with food at different storage timesthe skin test results of food extract at time 6 months after preparation |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Dermographism
- Severe systemic disease such as autoimmune disease, immune deficiency, malignancy
- Severe dermatitis or large area involment
- 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 |
|---|---|---|
| skin test with food at different storage timesPerform skin tests to each foods at 0, 3, 6 months after preparation and compare the results | Diagnostic test | Food skin tests at 0 month, Food skin tests at 3 month, Food skin tests at 6 month |
Primary outcome
skin test result of lyophilized foods at 6 months after preparation
Time frame: 6 month
Perform skin prick test and atopy patch test the patients with lyophilized foods at 0, 3 and 6 months after preparation and compare the results at 6 months to 0 and 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Undecided. Publication
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
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, MD principal investigator
Department of Pediatrics, Siriraj hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin test with food at different storage times in people with 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 3 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: finished, as of the sponsor's last update on 14 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin test result of lyophilized foods at 6 months after preparation (time frame: 6 month). 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 Aug 2019.