OIT Effect on FAQLQ

• Conditions: Food Allergy
• Interventions: Other: Oral immunotherapy

• Registration Number: NCT02375360
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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).

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 Timeline

• Study Start: 2014-07
• Status Verified: 2015-02
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-27
• Last Update Submitted: 2015-02-27
• Study First Posted: 2015-03-02
• Last Update Posted: 2015-03-02
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with suspected food allergy

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children 8-12 - OIT	Oral immunotherapy	Children aged 8-12 years with food allergy who are undergoing oral immunoterapy
Teenagers 13-17 - OIT	Oral immunotherapy	Teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy
Parents 0-12 - OIT	Oral immunotherapy	Parents to children aged 0-12 years with food allergy who are undergoing oral immunoterapy
Adults >18 - OIT	Oral immunotherapy	Adults\> 18 years with food allergy who are undergoing oral immunoterapy
Parents 13-17 - OIT	Oral immunotherapy	Parents to teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy

Primary Outcome Measures

Name	Time	Method
Quality of life	1 - 2 years

Trial Locations

Locations (1)

Asaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel