AllergyOIT followupNCT01999387
Follow up of Patients After Oral Immunotherapy for Cow's Milk, Eggs and Peanuts
An observational study of Allergy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction. Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts. Read more about this study
- Who is it for?
- Ages 4 to 40 years
- Conditions the study is for
- Allergy
- What is being tested?
- Allergenic food
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Dec 2016
- 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 4 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients > 4 years old with IgE mediated allergy to cow;s milk, eggs or peanuts who completed an OIT program >6 months ago
Who may be able to join
- age>4 years old IgE mediated allergy to milk eggs or peanuts Completion of OIT >6 months ago
Who cannot join
- Non approval to participate
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Asaf Harofeh Medical Center
Tsrifin, Israel, 70300
Arnon Elizur, 97289779820, elizura@gmail.com
About this study
Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.
Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts.
We conduct an oral immunotherapy program with ~500 patients so far. In this study we intent to follow patients who completed the program and assess their allergy status and quality of life.
Read the detailed description
Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.
Recently, oral immunotherapy (OIT) has emerged as an treatment for food allergy in milk eggs and peanuts. Since 4/2010,a clinical OIT program for milk eggs and peanuts is performed at the Institute fir Allergy Asthma and Immunology at Assaf Harofeh Medical Center with ~500 patients so far. Patients with IgE-mediated food allergy that are >4 years old are eligible.
In this study we intent to follow patients who completed the program. Patients will fill a questionnaire regarding current consumption of the allergenic food, adverse reactions experienced and treatments required including the use of EpiPen. Patients underwent skim prick tests (SPT) for the allergenic food prior to initiation and treatment and will undergo SPT again upon entering the study. Blood tests for IgE, IGG4, basophil activation and cytokines will be obtained.
Patients who are not consuming the allergenic food regularly will undergo an oral food challenge in clinic.
- Conditions
- Allergy
- Being tested
- Allergenic food
- Keywords
- food, consumption
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergenic foodDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Completed OIT | Patients who completed OIT >6 months prior to enrollment Receives: Dietary Supplement: Allergenic food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergenic food consumption questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yitzhak Katz, MD, Principal investigator, Asaf Harofeh Medical enter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999387
- Sponsor's protocol ID
- 41/13
- Acronym
- OIT followup
- Status last verified
- Jun 2013
- First submitted
- 26 Nov 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Patients After Oral Immunotherapy for Cow's Milk, Eggs and Peanuts
- ClinicalTrials.gov ID
- NCT01999387
- Acronym / sponsor ID
- OIT followup / 41/13
- Conditions
- Allergy
- Keywords
- food, consumption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Dec 2013 (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.
Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.
Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts.
We conduct an oral immunotherapy program with ~500 patients so far. In this study we intent to follow patients who completed the program and assess their allergy status and quality of life.
Detailed description
Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.
Recently, oral immunotherapy (OIT) has emerged as an treatment for food allergy in milk eggs and peanuts. Since 4/2010,a clinical OIT program for milk eggs and peanuts is performed at the Institute fir Allergy Asthma and Immunology at Assaf Harofeh Medical Center with ~500 patients so far. Patients with IgE-mediated food allergy that are >4 years old are eligible.
In this study we intent to follow patients who completed the program. Patients will fill a questionnaire regarding current consumption of the allergenic food, adverse reactions experienced and treatments required including the use of EpiPen. Patients underwent skim prick tests (SPT) for the allergenic food prior to initiation and treatment and will undergo SPT again upon entering the study. Blood tests for IgE, IGG4, basophil activation and cytokines will be obtained.
Patients who are not consuming the allergenic food regularly will undergo an oral food challenge in clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Completed OIT | – | Dietary Supplement: Allergenic foodPatients who completed OIT >6 months prior to enrollment |
Who may qualify
- Ages
- 4 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients > 4 years old with IgE mediated allergy to cow;s milk, eggs or peanuts who completed an OIT program >6 months ago
Key inclusion criteria (1 listed)
- age>4 years old IgE mediated allergy to milk eggs or peanuts Completion of OIT >6 months ago
Key exclusion criteria (1 listed)
- Non approval to participate
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 |
|---|---|---|
| Allergenic food | Dietary supplement | Completed OIT |
Primary outcome
Allergenic food consumption questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
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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.
Yitzhak Katz, MD principal investigator
Asaf Harofeh Medical enter
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 Allergy, run by Assaf-Harofeh 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 1 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 3 Dec 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yitzhak Katz, MD (97289779820, ykatz49@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergenic food consumption questionnaire (time frame: 6 months). 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 3 Dec 2013.