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The Feasibility of Systemic Reaction After Contact Exposure to the Allergenic Food in Children With Known Food Allergy

Primary Purpose

Food Allergy, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
application of the allergenic food
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Food Allergy focused on measuring food allergy, contact allergic reaction, skin prick test

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children aged one year to 18 years old with proven food allergy to one of the foods mentioned above.

Exclusion Criteria:

  • under 12 months of age
  • Admitted in the past in intensive care unit after allergic reaction
  • Had allergic reaction that treated with three or more adrenalin doses (EpiPen/ IM adrenaline)
  • Uncontrolled asthma (according to the GINA guidelines)
  • Severe AD
  • Children with allergy to three or more allergens not from the same allergen group

Sites / Locations

  • Allergy and Clinical Immunology UnitRecruiting
  • Meir medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

study subjects

Control - atopic children

Control - healthy children

Arm Description

Children with proven IgE-mediated food allergy to one of the allergenic foods described. Parallel to the skin tests that are done as part of the accepted follow-up: The parents will fill a questionnaire regarding the quality of life (QOL) and another questionnaire regards family and personal relevant medical history. Patch test sticker with the allergenic food will be placed on the forearm for 15 minutes. A week later and 2 months later, the same QOL questionnaire will be sent by e-mail.

Children with atopic comorbidities except for food allergy (ie. atopic dermatitis, asthma, allergic rhinitis). The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes.

Children without any atopic comorbidity (ie. atopic dermatitis, asthma, allergic rhinitis, and food allergy). The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes.

Outcomes

Primary Outcome Measures

reaction to the patch test
systemic or local reaction after the skin test with the patch test

Secondary Outcome Measures

change in quality of life
change in the perception of qality of life by the parents after a week and two months from the tests compared to qality of life questionnaire before the test. Quality of life scale is 0-84 and the highest the score the quality of life is lower.

Full Information

First Posted
September 27, 2021
Last Updated
October 18, 2021
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05080127
Brief Title
The Feasibility of Systemic Reaction After Contact Exposure to the Allergenic Food in Children With Known Food Allergy
Official Title
The Feasibility of Systemic Reaction After Contact Exposure to the Allergenic Food in Children With Known Food Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The prevalence of food allergy in the western world is a growing health problem. The majority of reactions are caused due to oral exposure to the known food allergen. However, there are reports about allergic symptoms after exposure to the allergenic food by contact and/ or inhalation. Most of those reports are subjective without an objective report of healthcare professionals. There are only a few prospective studies that observed objectively the "reliability" of those subjective reports. The estimated chance for systemic allergic reaction due to skin prick test with fresh food is 0.008%, and even then it will not cause anaphylaxis that will need epinephrine use. That evidence is in concordance with our experience. Even with all the information gathered, a study that examines the chance of systemic reaction after skin contact with the allergenic food is still missing. Additionally, lately, researchers start to examine the influence of food allergy on the quality of life (QOL) of allergic children and their parents. As expected, all studies show negative effects on QOL. The major concern of the parents is from random exposure and severe allergic reaction due to contact with the allergenic food. As far as the investigators know, no study examined the influence of supervised contact with allergenic food on the fear of the child and his parents. The study aims to evaluate the risk for a systemic allergic reaction after skin exposure to allergenic food in children with known food allergy.
Detailed Description
The prevalence of food allergy in the western world is estimated at 8% and is constantly raising. The majority of reactions are caused due to oral exposure to the known food allergen. However, there are reports about allergic symptoms after exposure to the allergenic food by contact and/ or inhalation. Most of those reports are subjective without an objective report of a healthcare professional. There is one description of a 16-year-old boy with cow's milk allergy (CMA), who developed anaphylaxis from skin exposure to small amount of cow's milk under the supervision of a healthcare professional. There are only a few prospective studies that observed objectively the "reliability" of those subjective reports. In 2003, Simonte SJ et al examine 30 children with known peanut allergy of which 19 reported past reactions after contact/ inhaled exposure to peanuts. They did a supervised exposure to contact and inhalation of peanut butter. They reported only local skin reactions such as redness (10%), itching (17%), and wheal and flare (7%) with no systemic reactions. Other studies examine the allergic reactions to skin contact with peanuts and also did not report on systemic reactions. In one of the studies they examine the allergic reaction to skin contact in 330 children allergic to peanuts and only 41% had a local reaction with no systemic reactions. In the second study, the investigators did the accepted skin prick test (SPT) with peanut and immediate skin application food test (I-SAFT) with peanut butter in 84 children. The investigators did not observe systemic allergic reactions. Only one study examined allergic reactions after contact with cow's milk in children with CMA. The aim of this study was to compare the skin reaction of children with CMA with and without atopic dermatitis (AD). The investigators did not report systemic reactions also. There are few cases reports that described systemic allergic reaction during SPT, all cases were with fish allergy. A large study examined reactions to SPT with fresh food on 1,138 allergic patients. The investigators have shown that the chance of systemic allergic reaction is 0.008%, and none of the cases needed epinephrine. They review other 15 studies and did not find evidence to systemic reaction after SPT except for one study that reported a 0.005% prevalence of systemic reaction to follow SPT with fresh food in infants younger than 6 months of age. That evidence is in concordance with the investigators experience. Until today, the investigators did not see the systemic reaction after SPT in children with food allergies. Even with all the information gathered, a study that examines the chance of systemic reaction after skin contact with the allergenic food is still missing. Additionally, lately, researchers start to examine the influence of food allergy on the quality of life (QOL) of allergic children and their parents. As expected, all studies show a negative effect on QOL. The major concern of the parents is from random exposure and severe allergic reaction due to contact with the allergenic food. As far as the investigator know, no study examined the influence of supervised contact with allergenic food on the fear of the child and his parents. The study aims primarily - to evaluate the risk for a systemic allergic reaction after skin exposure to the allergenic food in children with known food allergies. secondary - 1. To evaluate the QOL of the parents (and children over 8 years) before and after the contact with the allergenic food. Methods: 500 children with known food allergy and 100 children without food allergy as a control group. Simultaneously to the regular skin prick tests, a patch test sticker with the allergenic food will be placed on the forearm for 15 minutes. The parents will fill quality of life questionnaire before the tests, a week later, and 2 months later. expected results - No allergic reaction will occur after the patch test other than mild local reaction. the level of anxiety will be reduced after the tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Quality of Life
Keywords
food allergy, contact allergic reaction, skin prick test

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
study group - 500 children with known food allergy control groups - A. 50 children with atopic comorbidities but no food allergy. B. 50 children without atopic comorbidities
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study subjects
Arm Type
Experimental
Arm Description
Children with proven IgE-mediated food allergy to one of the allergenic foods described. Parallel to the skin tests that are done as part of the accepted follow-up: The parents will fill a questionnaire regarding the quality of life (QOL) and another questionnaire regards family and personal relevant medical history. Patch test sticker with the allergenic food will be placed on the forearm for 15 minutes. A week later and 2 months later, the same QOL questionnaire will be sent by e-mail.
Arm Title
Control - atopic children
Arm Type
Active Comparator
Arm Description
Children with atopic comorbidities except for food allergy (ie. atopic dermatitis, asthma, allergic rhinitis). The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes.
Arm Title
Control - healthy children
Arm Type
Active Comparator
Arm Description
Children without any atopic comorbidity (ie. atopic dermatitis, asthma, allergic rhinitis, and food allergy). The parents will fill a questionnaire regarding family and personal relevant medical history and foods that the child is exposed to regularly. Patch test stickers with two of the food allergen list will be placed on the forearm for 15 minutes.
Intervention Type
Combination Product
Intervention Name(s)
application of the allergenic food
Intervention Description
a small amount of the allergenic fresh food will be placed on the forearm using a patch test sticker for 15 minutes. the skin reaction will be measured.
Primary Outcome Measure Information:
Title
reaction to the patch test
Description
systemic or local reaction after the skin test with the patch test
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
change in quality of life
Description
change in the perception of qality of life by the parents after a week and two months from the tests compared to qality of life questionnaire before the test. Quality of life scale is 0-84 and the highest the score the quality of life is lower.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged one year to 18 years old with proven food allergy to one of the foods mentioned above. Exclusion Criteria: under 12 months of age Admitted in the past in intensive care unit after allergic reaction Had allergic reaction that treated with three or more adrenalin doses (EpiPen/ IM adrenaline) Uncontrolled asthma (according to the GINA guidelines) Severe AD Children with allergy to three or more allergens not from the same allergen group
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Idit Lachover- Roth, MD
Phone
972-54-3152585
Email
idit.roth@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idit Lachover- Roth, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy and Clinical Immunology Unit
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idit Lachover- Roth, MD
Phone
972-54-3152585
Email
idit.roth@clalit.org.il
Facility Name
Meir medical center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idit Lachover - Roth, MD
Phone
972-54-3152585
Email
idit.roth@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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24388012
Citation
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The Feasibility of Systemic Reaction After Contact Exposure to the Allergenic Food in Children With Known Food Allergy

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