The SunBEAm birth cohort: Protocol design.

Background

Food allergy (FA) and atopic dermatitis (AD) are common conditions that often present in the first year of life. Identification of underlying mechanisms and environmental determinants of FA and AD is essential to develop and implement effective prevention and treatment strategies. Objectives: We sought to describe the design of the Systems Biology of Early Atopy (SunBEAm) birth cohort.

Methods

Funded by the National Institute of Allergy and Infectious Diseases (NIAID) and administered through the Consortium for Food Allergy Research (CoFAR), SunBEAm is a US population-based, multicenter birth cohort that enrolls pregnant mothers, fathers, and their newborns and follows them to 3 years. Questionnaire and biosampling strategies were developed to apply a systems biology approach to identify environmental, immunologic, and multiomic determinants of AD, FA, and other allergic outcomes.

Results

Enrollment is currently underway. On the basis of an estimated FA prevalence of 6%, the enrollment goal is 2500 infants. AD is defined on the basis of questionnaire and assessment, and FA is defined by an algorithm combining history and testing. Although any FA will be recorded, we focus on the diagnosis of egg, milk, and peanut at 5 months, adding wheat, soy, cashew, hazelnut, walnut, codfish, shrimp, and sesame starting at 12 months. Sampling includes blood, hair, stool, dust, water, tape strips, skin swabs, nasal secretions, nasal swabs, saliva, urine, functional aspects of the skin, and maternal breast milk and vaginal swabs.

Conclusions

The SunBEAm birth cohort will provide a rich repository of data and specimens to interrogate mechanisms and determinants of early allergic outcomes, with an emphasis on FA, AD, and systems biology.

Déclaration de conflit d'intérêts

DISCLOSURE STATEMENT Funded by the following grants from NIAID/National Institutes of Health (NIH): UM2AI130836, UM1AI130838, UM1AI130839, UM1AI130781, UM1AI130936, UM1AI130936, UM1AI130780, UM1AI130934, UM1AI130570, UM1AI173380, UM1AI151958, and UM1AI109565. The authorships of P.C.F., A.T., W.D., S.H., and S.P. do not constitute endorsement by the National Institute of Allergy and Infection Diseases, the National Institutes of Health, or any other agency of the United States government. Disclosure of potential conflict of interest: C. Keet reports royalties from UpToDate. S. H. Sicherer reports royalty payments from UpToDate and Johns Hopkins University Press; grants to his institution from NIAID, Food Allergy Research and Education, and Pfizer; personal fees from the American Academy of Allergy, Asthma & Immunology; and deputy editorship of the Journal of Allergy and Clinical Immunology: In Practice, outside of the submitted work. C. M. Davis reports grant support from NIAID/NIH, Immune Tolerance Network, DBV Technologies, Regeneronm Pfizer, and Allergenis; and consultant for Aimmune. S. Anvari reports research support from NIAID/NIH and DBV Technologies; and serves on the advisory board for Sanofi. M. Groetch receives royalties from UpToDate, FARE, and the Academy of Nutrition and Dietetics; serves on the medical advisory board of IFPIES, as senior advisor to FARE, and as health sciences advisor for APFED; and sits on the editorial board of Journal of Food Allergy. W. Shreffler reports royalty payments from UpToDate; grants to his institution from NIAID and Food Allergy Research and Education; sponsored research funds from Aimune, Angany Therapeutics, Moderna, Regeneron, Vedanta Biosciences and consultant fees from Aimmune, ALK, Allergy Therapeutics, Novartis, Regeneron, and Sanofi. Dr. Leung reports support from Sanofi, Genentech, Leo Pharma, and Incyte. H. Kim reports advisory board for ALK, Kenota Health, and Ukko Inc; consultant for Allergy Therapeutics Ltd, Belhaven Biopharma, Duke Clinical Research Institute, Genentech, and Nutricia. J. Wang receives research support from NIAID, Aimmune, DBV Technologies, and Regeneron; and consultancy fees from ALK Abello and Jubilant HollisterStier. R. A. Wood reports research support from NIAID, Aimmune, Astellas, DBV, FARE, Genentech, HAL-Allergy, Novartis, and Regeneron; and royalties from UpToDate. The rest of the authors declare that they have no relevant conflicts of interest.