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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk Atopic Infants | Other | 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. |
|
| Atopic Adults | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluating atopy in infants | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pia Hauk, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16128978 | Background | Walker L, Downe S, Gomez L. Skin care in the well term newborn: two systematic reviews. Birth. 2005 Sep;32(3):224-8. doi: 10.1111/j.0730-7659.2005.00374.x. | |
| 22011065 | Background | Blume-Peytavi U, Hauser M, Stamatas GN, Pathirana D, Garcia Bartels N. Skin care practices for newborns and infants: review of the clinical evidence for best practices. Pediatr Dermatol. 2012 Jan-Feb;29(1):1-14. doi: 10.1111/j.1525-1470.2011.01594.x. Epub 2011 Oct 20. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C116241 | MICU1 protein, human |
| D012680 | Sensitivity and Specificity |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D013223 | Statistics as Topic |
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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.
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|
| Evaluating TEWL and STS in adults | Other | 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. |
|
|
Food Allergen Sensitization measured by positive skin prick testing to milk, egg, and peanut measured as positive or negative |
| 12 months |
| 24128970 | Background | Elias PM. Lipid abnormalities and lipid-based repair strategies in atopic dermatitis. Biochim Biophys Acta. 2014 Mar;1841(3):323-30. doi: 10.1016/j.bbalip.2013.10.001. Epub 2013 Oct 12. |
| 7611797 | Background | Mao-Qiang M, Brown BE, Wu-Pong S, Feingold KR, Elias PM. Exogenous nonphysiologic vs physiologic lipids. Divergent mechanisms for correction of permeability barrier dysfunction. Arch Dermatol. 1995 Jul;131(7):809-16. doi: 10.1001/archderm.131.7.809. |
| 24262790 | Background | Feingold KR, Elias PM. Role of lipids in the formation and maintenance of the cutaneous permeability barrier. Biochim Biophys Acta. 2014 Mar;1841(3):280-94. doi: 10.1016/j.bbalip.2013.11.007. Epub 2013 Nov 18. |
| 25282563 | Background | Simpson EL, Chalmers JR, Hanifin JM, Thomas KS, Cork MJ, McLean WH, Brown SJ, Chen Z, Chen Y, Williams HC. Emollient enhancement of the skin barrier from birth offers effective atopic dermatitis prevention. J Allergy Clin Immunol. 2014 Oct;134(4):818-23. doi: 10.1016/j.jaci.2014.08.005. |
| 25282564 | Background | Horimukai K, Morita K, Narita M, Kondo M, Kitazawa H, Nozaki M, Shigematsu Y, Yoshida K, Niizeki H, Motomura K, Sago H, Takimoto T, Inoue E, Kamemura N, Kido H, Hisatsune J, Sugai M, Murota H, Katayama I, Sasaki T, Amagai M, Morita H, Matsuda A, Matsumoto K, Saito H, Ohya Y. Application of moisturizer to neonates prevents development of atopic dermatitis. J Allergy Clin Immunol. 2014 Oct;134(4):824-830.e6. doi: 10.1016/j.jaci.2014.07.060. |
| 22310478 | Background | Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6. |
| 22191005 | Background | Kircik LH, Del Rosso JQ. Nonsteroidal treatment of atopic dermatitis in pediatric patients with a ceramide-dominant topical emulsion formulated with an optimized ratio of physiological lipids. J Clin Aesthet Dermatol. 2011 Dec;4(12):25-31. |
| 26924469 | Background | Kelleher MM, Dunn-Galvin A, Gray C, Murray DM, Kiely M, Kenny L, McLean WHI, Irvine AD, Hourihane JO. Skin barrier impairment at birth predicts food allergy at 2 years of age. J Allergy Clin Immunol. 2016 Apr;137(4):1111-1116.e8. doi: 10.1016/j.jaci.2015.12.1312. |
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| 23891354 | Background | Peters RL, Allen KJ, Dharmage SC, Tang ML, Koplin JJ, Ponsonby AL, Lowe AJ, Hill D, Gurrin LC; HealthNuts Study. Skin prick test responses and allergen-specific IgE levels as predictors of peanut, egg, and sesame allergy in infants. J Allergy Clin Immunol. 2013 Oct;132(4):874-80. doi: 10.1016/j.jaci.2013.05.038. Epub 2013 Jul 24. |
| 15125698 | Background | Halken S. Prevention of allergic disease in childhood: clinical and epidemiological aspects of primary and secondary allergy prevention. Pediatr Allergy Immunol. 2004 Jun;15 Suppl 16:4-5, 9-32. doi: 10.1111/j.1399-3038.2004.0148b.x. |
| 26031325 | Background | Minasyan A, Babajanyan A, Campbell DE, Nanan R. Validation of a Comprehensive Early Childhood Allergy Questionnaire. Pediatr Allergy Immunol. 2015 Sep;26(6):522-9. doi: 10.1111/pai.12415. Epub 2015 Jul 22. |
| 23458265 | Background | Kelleher MM, O'Carroll M, Gallagher A, Murray DM, Dunn Galvin A, Irvine AD, Hourihane JO. Newborn transepidermal water loss values: a reference dataset. Pediatr Dermatol. 2013 Nov-Dec;30(6):712-6. doi: 10.1111/pde.12106. Epub 2013 Mar 5. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D055641 | Mathematical Concepts |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |