Atopic Dermatitis, Eczema, Food Allergy
Conditions
Keywords
Prevention, Predictors
Brief summary
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.
Interventions
OTHEREvaluating atopy in infants
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.
OTHEREvaluating TEWL and STS in adults
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.
Sponsors
National Jewish Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
34 Weeks to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serial Transepidermal Water Loss (TEWL) | 12 months | Skin Barrier Assessment measured through serial transepidermal water loss (TEWL) in grams of water/meters-squared/hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Tape Stripping (STS) and Filaggrin(FLG) breakdown products | Up to 12 months | Risk of atopic dermatitis as evaluated through FLG breakdown products, lipid composition in the skin, and skin ape strip samples |
| Skin prick testing to milk, egg, and peanut | 12 months | Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative |
Countries
United States
Outcome results
None listed