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OIT Effect on FAQLQ

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ClinicalTrials.gov Identifier: NCT02375360
Recruitment Status : Unknown
Verified February 2015 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : March 2, 2015
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Food Allergy Other: Oral immunotherapy

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quality of Life in Food Allergic Patients Before, During and After Oral Immunotherapy
Study Start Date : July 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 1 - 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children, teenagers and their parents and adults with food allergy
Criteria

Inclusion Criteria:

  • Patients with suspected food allergy

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375360


Locations
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Israel
Asaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Arnon Elizur    97289779820    elizura@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center

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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02375360     History of Changes
Other Study ID Numbers: 52/14
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases