OIT Effect on FAQLQ

February 27, 2015 updated by: Assaf-Harofeh Medical Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Asaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children, teenagers and their parents and adults with food allergy

Description

Inclusion Criteria:

  • Patients with suspected food allergy

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Oral immunotherapy
Teenagers 13-17 - OIT
Teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy
Other: Oral immunotherapy
Adults >18 - OIT
Adults> 18 years with food allergy who are undergoing oral immunoterapy
Other: Oral immunotherapy
Parents 0-12 - OIT
Parents to children aged 0-12 years with food allergy who are undergoing oral immunoterapy
Other: Oral immunotherapy
Parents 13-17 - OIT
Parents to teenagers aged 13-17 years with food allergy who are undergoing oral immunoterapy
Other: Oral immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 1 - 2 years
1 - 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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