Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

Study Overview
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Brief Summary
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It is hypothesized that food allergy is preceded by atopic dermatitis (AD), due to a disruption of skin barrier which can predispose one to food sensitization through the skin. The central hypothesis is that increased transepidermal water loss (TEWL) assessment and skin tape strip analysis (STS) of lipid and filaggrin breakdown products will be predictive markers for the development of AD. Additionally, the associated changes in TEWL and STS will further improve the identification of infants at risk of early food sensitization, compared to family history alone.

Official Title
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Hypothesis: Skin Barrier Dysfunction With Altered Expression of Skin Barrier Proteins and Lipids Predicts Early Food Sensitizations in Infants at High Risk of Atopy

Conditions
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Atopic Dermatitis, Eczema, Food Allergy

Intervention / Treatment
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* Other: Evaluating atopy in infants
* Other: Evaluating TEWL and STS in adults


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with physician confirmed pregnancy at a gestational age of ≥ 34 weeks. Infants at high risk for atopy will have one or both parents affected by an allergic disease. Infants at low risk for atopy will have no parent or sibling affected by allergic disease. Biologic parent(s) of infants at high risk of atopy will also be enrolled in the study. Exclusion Criteria: Pregnancy loss or delivery prior to a gestational age of ≥ 34 weeks, a history of substance or alcohol abuse, psychiatric and developmental co-morbidities that would render a subject unable to provide informed consent or perform study-related procedures, AIDS and HIV infection, or a fetus with chromosomal or congenital abnormalities.

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Children at high risk of atopy will be followed up to 6 months of age. The investigator will obtain TEWL measurements, skin tape stripping, and questionnaire data each subsequent visit. During the latter 2 visits, skin prick allergy testing will be obtained for milk, egg, and peanut to determine risk of food allergy. Biologic parents will also undergo STS and TEWL measurements on the first visit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Risk Atopic Infants<br>Infants, who are at high risk of atopy, which will be determined by a validated questionnaire, will be enrolled. Infants will undergo skin tape stripping (STS), transepidermal water loss assessment (TEWL), bacterial swabs, and parental questionnaires at each visit (3 visits total). At the latter 2 visits, infants will also undergo skin prick testing to evaluate for food sensitization. | Other: Evaluating atopy in infants<br>* This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.<br>* Other names: Allergies;|
| Other: Atopic Adults<br>Parents of infants enrolled in the study will undergo skin tape stripping (STS), transepidermal water loss assessment (TEWL), and complete questionnaires at the first visit. | Other: Evaluating TEWL and STS in adults<br>* This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.<br>* Other names: Skin tape stripping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial Transepidermal Water Loss (TEWL) | Skin Barrier Assessment measured through serial transepidermal water loss (TEWL) in grams of water/meters-squared/hour | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products | Risk of atopic dermatitis as evaluated through FLG breakdown products, lipid composition in the skin, and skin ape strip samples | Up to 12 months | 
| Skin prick testing to milk, egg, and peanut | Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Predictors