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

NCT05080127 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

application of the allergenic food

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.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Idit Lachover- Roth, MD · Meir Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2023-07-31
Completion
2023-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05080127 on ClinicalTrials.gov