Food AllergyNCT01508299
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food
A study testing skin test in people with Food Allergy, run by Meir Medical Center at 1 site in Israel.
Trial summary
Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal and reproduce false negative results (no allergy) in patients with history highly suggestive of allergic reaction. Read more about this study
- Who is it for?
- Ages 1 month to 120 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- skin test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Apr 2015
- 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 1 month to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspected immediate allergic reaction to food
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Allergy and clinical immunology unit , Meir hospital
Kfar Saba, Israel, 44281
About this study
Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal and reproduce false negative results (no allergy) in patients with history highly suggestive of allergic reaction. The aim of this study is to compare the reproducibility of different commercial extracts and raw food in patients with convincing history of acute allergic symptoms related to food .
- Conditions
- Food Allergy
- Being tested
- skin test
- Keywords
- skin test, raw food, commercial extract
- 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 testProcedure or surgery
skin test with the Suspected raw food
| Study group | Role | What they receive |
|---|---|---|
| raw food skin test | Experimental | skin test with the suspected raw food Receives: Procedure: skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between the results of skin test with commercial extracts and raw food
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2015
- Study completionApr 2015
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnon Goldberg, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508299
- Sponsor's protocol ID
- crufood1
- Status last verified
- Oct 2015
- First submitted
- 9 Jan 2012
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food
- ClinicalTrials.gov ID
- NCT01508299
- Acronym / sponsor ID
- crufood1
- Conditions
- Food Allergy
- Keywords
- skin test, raw food, commercial extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Jan 2012 (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.
Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal and reproduce false negative results (no allergy) in patients with history highly suggestive of allergic reaction. The aim of this study is to compare the reproducibility of different commercial extracts and raw food in patients with convincing history of acute allergic symptoms related to food .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| raw food skin test | Experimental | Procedure: skin testskin test with the suspected raw food |
Who may qualify
- Ages
- 1 month to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected immediate allergic reaction to food
Key exclusion criteria (0 listed)
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 testskin test with the Suspected raw food | Procedure or surgery | raw food skin test |
Primary outcome
correlation between the results of skin test with commercial extracts and raw food
Time frame: immediate
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 7 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Food Allergy, run by Meir Medical Center at 1 site in Israel.
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 0 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 7 Oct 2015. 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 Israel. 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?
correlation between the results of skin test with commercial extracts and raw food (time frame: immediate). 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 7 Oct 2015.