# National Jewish Health CoFAR Clinical Research Unit

> **NIH NIH UM1** · NATIONAL JEWISH HEALTH · 2023 · $234,998

## Abstract

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.

## Key facts

- **NIH application ID:** 10569513
- **Project number:** 5UM1AI130780-07
- **Recipient organization:** NATIONAL JEWISH HEALTH
- **Principal Investigator:** Donald YM Leung
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $234,998
- **Award type:** 5
- **Project period:** 2017-03-02 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10569513

## Citation

> US National Institutes of Health, RePORTER application 10569513, National Jewish Health CoFAR Clinical Research Unit (5UM1AI130780-07). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10569513. Licensed CC0.

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