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NCT02375360 Clinical Trial

OIT Effect on FAQLQ

Food Allergy Clinical Trial

Official title:
Quality of Life in Food Allergic Patients Before, During and After Oral Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02375360
Other study ID # 52/14
Secondary ID
Status Recruiting
Phase N/A
First received February 24, 2015
Last updated February 27, 2015
Start date July 2014

Study information
Verified date February 2015
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with suspected food allergy

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Oral immunotherapy

Locations
Country Name City State
Israel Asaf Harofeh Medical Center Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life 1 - 2 years No
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