Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy

National Jewish Health

Status: Withdrawn

Conditions: Atopic Dermatitis; Food Allergy; Eczema

Treatments: Other: Evaluating TEWL and STS in adults; Other: Evaluating atopy in infants

Study type: Interventional

Funder types: Other

Identifiers

NCT03089476

3083

Details and patient eligibility

About

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.

Sex: All

Ages: 34 weeks to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

High Risk Atopic Infants

Other group

Description:

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.

Treatment:

Other: Evaluating atopy in infants

Atopic Adults

Other group

Description:

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.

Treatment:

Other: Evaluating TEWL and STS in adults