NCT02375360

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

February 24, 2015

Last Update Submit

February 27, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    1 - 2 years

Study Arms (7)

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

Interventions

Adults >18 - OITChildren 8-12 - OITParents 0-12 - OITParents 13-17 - OITTeenagers 13-17 - OIT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children, teenagers and their parents and adults with food allergy

You may qualify if:

  • Patients with suspected food allergy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofeh Medical Center

Ẕerifin, Israel, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2016

Last Updated

March 2, 2015

Record last verified: 2015-02

Locations