One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish

Food Allergy Clinical Trial

Official title:

One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640560
• Other study ID #: 10/2012
• Status: Completed
• Phase: N/A
• First received: December 9, 2015
• Last updated: December 23, 2015
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

Inclusion criteria

• 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.

Exclusion criteria

• Patients/subjects in acute phase of disease or with not controlled chronic pathologies;

• missing written informed consent by parents

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anaphylaxis
• Food Allergy
• Food Hypersensitivity

Intervention

Other:
• Food allergy questionnaire
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 Questionnaire
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stefania La Grutta, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Anaphylaxis in 1 year	To determine the frequency of anaphylaxis in allergic outpatient children	1 year	No