Food AllergyNCT02375360
OIT Effect on FAQLQ
An observational study of Food Allergy, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled also by patients undergoing oral immunotherapy (OIT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Allergy
- What is being tested?
- Oral immunotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children, teenagers and their parents and adults with food allergy
Who may be able to join
- Patients with suspected food allergy
Who cannot join
- none
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
Official title: Quality of Life in Food Allergic Patients Before, During and After Oral Immunotherapy
Patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled also by patients undergoing oral immunotherapy (OIT).
Read the detailed description
The food allergy quality of life questionnaires (FAQLQ) for children 8-12 y/o, teenagers 13-17 y/o and adults > 18 y/o and parents to children 0-12 y/o and to teenagers will be translated to Hebrew. Questionnaires will be given to patients with food allergy followed at Asaf Harofeh Medical Center. Questionnaires will be examined for internal consistency. The Food Allergy Independent Measure (FAIM) questionnaire for the same age groups will also be translated to Hebrew. The FAQLQ will be validated by correlation with the FAIM.
The questionnaires will then be administered to patients and families undergoing food oral immunotherpy, before during and following treatment.
- Conditions
- Food Allergy
- Being tested
- Oral immunotherapy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral immunotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Children 8-12- control | Children aged 8-12 years with food allergy who are not undergoing oral immunoterapy | |
| Parents 0-12 - control | Parents to children aged 0-12 years with food allergy who are not undergoing oral immunoterapy | |
| Children 8-12 - OIT | Children aged 8-12 years with food allergy who are undergoing oral immunoterapy Receives: Other: Oral immunotherapy | |
| Teenagers 13-17 - OIT | Teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy Receives: Other: Oral immunotherapy | |
| Adults >18 - OIT | Adults> 18 years with food allergy who are undergoing oral immunoterapy Receives: Other: Oral immunotherapy | |
| Parents 0-12 - OIT | Parents to children aged 0-12 years with food allergy who are undergoing oral immunoterapy Receives: Other: Oral immunotherapy | |
| Parents 13-17 - OIT | Parents to teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy Receives: Other: Oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 1 - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375360
- Sponsor's protocol ID
- 52/14
- Status last verified
- Feb 2015
- First submitted
- 24 Feb 2015
- Last updated
- 2 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Food Allergic Patients Before, During and After Oral Immunotherapy
- ClinicalTrials.gov ID
- NCT02375360
- Acronym / sponsor ID
- 52/14
- Conditions
- Food Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 2 Mar 2015 (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.
Patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to Hebrew and validated. Questionnaires will be filled also by patients undergoing oral immunotherapy (OIT).
Detailed description
The food allergy quality of life questionnaires (FAQLQ) for children 8-12 y/o, teenagers 13-17 y/o and adults > 18 y/o and parents to children 0-12 y/o and to teenagers will be translated to Hebrew. Questionnaires will be given to patients with food allergy followed at Asaf Harofeh Medical Center. Questionnaires will be examined for internal consistency. The Food Allergy Independent Measure (FAIM) questionnaire for the same age groups will also be translated to Hebrew. The FAQLQ will be validated by correlation with the FAIM.
The questionnaires will then be administered to patients and families undergoing food oral immunotherpy, before during and following treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Children 8-12- control | – | –Children aged 8-12 years with food allergy who are not undergoing oral immunoterapy |
| Parents 0-12 - control | – | –Parents to children aged 0-12 years with food allergy who are not undergoing oral immunoterapy |
| Children 8-12 - OIT | – | Other: Oral immunotherapyChildren aged 8-12 years with food allergy who are undergoing oral immunoterapy |
| Teenagers 13-17 - OIT | – | Other: Oral immunotherapyTeenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy |
| Adults >18 - OIT | – | Other: Oral immunotherapyAdults> 18 years with food allergy who are undergoing oral immunoterapy |
| Parents 0-12 - OIT | – | Other: Oral immunotherapyParents to children aged 0-12 years with food allergy who are undergoing oral immunoterapy |
| Parents 13-17 - OIT | – | Other: Oral immunotherapyParents to teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children, teenagers and their parents and adults with food allergy
Key inclusion criteria (1 listed)
- Patients with suspected food allergy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Oral immunotherapy | Other | Adults >18 - OIT, Children 8-12 - OIT, Parents 0-12 - OIT, Parents 13-17 - OIT, Teenagers 13-17 - OIT |
Primary outcome
Quality of life
Time frame: 1 - 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
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 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 2 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 1 - 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 2 Mar 2015.