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Clinical Trial Summary

The purpose of this study is to determine whether disruptions in the skin barrier of parents can contribute to the development of food allergies in their offspring. The study team will compare the superficial skin layers of mothers and fathers who do not have children with diagnosed food allergies to the skin layers of parents who do have children with diagnosed food allergy. The study will include a questionnaire, noninvasive superficial skin testing with skin tapping and transepidermal water loss measurements, and a blood draw.


Clinical Trial Description

There is an already well-established link between atopic dermatitis (AD), or eczema, and the development of food allergies. More specifically, it is believed that sensitizations to food can occur through low-dose cutaneous sensitization via a disrupted skin barrier. The strongest genetic contributor to eczema is the FLG loss-of-function or missense mutation, which is associated with increased transepidermal water loss and increased skin permeability (1). In a recent study exploring the risk of maternal transmission of allergic risk, it was found that children of FLG-carrier mothers had a 1.5 increased AD risk, specifically when these mothers had allergic sensitization (elevated allergen-specific IgE antibody plasma levels) but independent of their own FLG mutation status (10). This information may suggest that an interrupted skin barrier in mothers may serve as an environmental risk factor for the development of food allergies in their offspring.

The purpose of our study is to evaluate the skin characteristics and FLG gene mutation status of parents of known food allergic pediatric patients. The researchers hypothesize that parents of food allergic patients will have more significant disruptions in their skin barrier function than parents of children who do not suffer from food allergies.

In order to evaluate skin barrier disruptions in these subjects, two noninvasive methods will be performed including skin tape stripping, a total of 30 strips per subject, and transepidermal water loss measurements using a small device. Both methods are relatively painless and cause minimal risk to the participant. In order to evaluated FLG gene mutation status, blood draw will also be performed. Subjects will undergo a focused physical exam and also be requested to fill out a detailed questionnaire. The researchers will obtain additional offspring peanut allergy clinical characteristics from the medical records. All data collection will occur over 1-2 visits, averaging an anticipated 1 hour in total duration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04198753
Study type Observational
Source National Jewish Health
Contact
Status Suspended
Phase
Start date January 23, 2020
Completion date October 6, 2020

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