National Jewish Health CoFAR Clinical Research Unit

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Project Summary/Abstract This application is being submitted in response to RFA-AI-15-051, Consortium for Food Allergy Research (CoFAR): Clinical Research Units (UM1). The goal of this proposal is to establish an infrastructure and clinical strategies to prevent and manage food allergy (FA). Our central hypothesis is that prevention of skin barrier dysfunction and atopic dermatitis (AD) complicated by Staphylococcus aureus infection using a linoleic acid containing sunflower seed oil with anti-inflammatory, anti-microbial, and skin barrier enhancing properties will prevent early skin allergen exposure and thereby prevent the occurrence of FA at two years of age. We will achieve our objectives with the following aims: · Specific Aim 1: To establish an Administration and Operations Element that will be responsible for implementation of clinical trials and studies for the Consortium in the areas of prevention and treatment of FA as well as an understanding of its underlying mechanisms. The Clinical Research Unit will also provide an environment for New and Early Stage Investigators to develop research skills and assist them in progressing to more senior status through their work in CoFAR. · Specific Aim 2: To perform a Clinical Trial to determine if prevention of skin barrier dysfunction, AD and S. aureus colonization using linoleic acid containing sunflower seed oil will reduce the occurrence of FA in a prospective, randomized, controlled clinical Birth Cohort study of individuals at high risk vs. low risk of atopy. The primary clinical hypothesis is that introduction of a linoleic acid containing sunflower seed oil from birth will prevent systemic IgE allergen sensitization and clinical FA commonly associated with AD (e.g. egg, milk, peanut, soy, wheat, tree nuts and others). · Specific Aim 3: To determine if prevention of AD and S. aureus colonization using a linoleic acid containing sunflower seed oil will reduce the occurrence of persistent FA and respiratory allergy later in childhood. This secondary clinical hypothesis is that introduction of a linoleic acid containing sunflower seed oil will reduce the occurrence of persistent FA as well as sensitization to environmental allergies and asthma which is known to be associated with more severe food allergic reactions and anaphylaxis. This clinical Birth Cohort Study will provide a framework for establishment of a data and biological specimen repository (specific aim 4) to allow future studies of the role of skin barrier function and pathogenic mechanisms related to FA.