Food AllergyNCT02640560
One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish
An observational study of Food Allergy, run by Stefania La Grutta, MD.
Trial summary
In Italy, few data about anaphylaxis due to peanuts in pediatric age are available, conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been collected. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Food allergy questionnaire
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Apr 2014
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: 200 Italian children with or without food allergy
Who may be able to join
- Cases: 0-14 years old patients with food allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.
- Controls: 0-14 years old subjects without allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.
Who cannot join
- Patients/subjects in acute phase of disease or with not controlled chronic pathologies;
- missing written informed consent by parents
About this study
In Italy, few data about anaphylaxis due to peanuts in pediatric age are available, conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been collected.
Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).
Read more
Parent of food allergic children will compile a food allergy questionnaire (questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources).
Parent of healthy children will compile a control questionnaire (questions about general information on the family, on life and food habits and on indoor environment) The 1-year survey will determine the frequency of anaphylaxis in allergic outpatient children.
- Conditions
- Food Allergy
- Being tested
- Food allergy questionnaire, Control Questionnaire
- Keywords
- Children, Allergy, Peanuts, Hazelnuts, Walnuts, Mollusks, Shellfish, Food
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food allergy questionnaireOther
The Parents of the cases children will compile a questionnaire including questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources
Control QuestionnaireOther
The Parents of the control children will compile a questionnaire including questions about general information on the family, on life and food habits and on indoor environment.
| Study group | Role | What they receive |
|---|---|---|
| Children with food allergy | Children with food allergy to nuts, hazelnuts, walnuts, shellfish and mollusks (1-14 years old).
The Parents of the cases children will compile a Food allergy questionnaire Receives: Other: Food allergy questionnaire | |
| Healthy Children | Healthy Children (1-14 years old) The Parents of the control children will compile a Control questionnaire Receives: Other: Control Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Anaphylaxis in 1 year
To determine the frequency of anaphylaxis in allergic outpatient children
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania La Grutta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640560
- Sponsor's protocol ID
- 10/2012
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish
- ClinicalTrials.gov ID
- NCT02640560
- Acronym / sponsor ID
- 10/2012
- Conditions
- Food Allergy
- Keywords
- Children, Allergy, Peanuts, Hazelnuts, Walnuts, Mollusks, Shellfish, Food
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Dec 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.
In Italy, few data about anaphylaxis due to peanuts in pediatric age are available, conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been collected.
Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).
Parent of food allergic children will compile a food allergy questionnaire (questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources).
Parent of healthy children will compile a control questionnaire (questions about general information on the family, on life and food habits and on indoor environment) The 1-year survey will determine the frequency of anaphylaxis in allergic outpatient children.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with food allergy | – | Other: Food allergy questionnaireChildren with food allergy to nuts, hazelnuts, walnuts, shellfish and mollusks (1-14 years old). The Parents of the cases children will compile a Food allergy questionnaire |
| Healthy Children | – | Other: Control QuestionnaireHealthy Children (1-14 years old) The Parents of the control children will compile a Control questionnaire |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 200 Italian children with or without food allergy
Key inclusion criteria (2 listed)
- Cases: 0-14 years old patients with food allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.
- Controls: 0-14 years old subjects without allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.
Key exclusion criteria (2 listed)
- Patients/subjects in acute phase of disease or with not controlled chronic pathologies;
- missing written informed consent by parents
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 |
|---|---|---|
| Food allergy questionnaireThe Parents of the cases children will compile a questionnaire including questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources | Other | Children with food allergy |
| Control QuestionnaireThe Parents of the control children will compile a questionnaire including questions about general information on the family, on life and food habits and on indoor environment. | Other | Healthy Children |
Primary outcome
Frequency of Anaphylaxis in 1 year
Time frame: 1 year
To determine the frequency of anaphylaxis in allergic outpatient children
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 29 Dec 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Stefania La Grutta, MD.
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 2 inclusion and 2 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Frequency of Anaphylaxis in 1 year (time frame: 1 year). 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 29 Dec 2015.