Lurie Children’s Study to Use Soy Isoflavones in a Precision Medicine Approach to Prevent Wheezing and Asthmatic Inflammation in High Risk Infants

Rajesh Kumar, MD, and Jacqueline Pongracic, MD, from Ann & Robert H. Lurie Children’s Hospital of Chicago received $3 million from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) for a site-specific clinical trial on whether a soy supplement in infancy can prevent asthma in children with a high-risk genetic variation. This will be one of the earliest precision medicine approaches to asthma prevention.

Rajesh Kumar, MD, and Jacqueline Pongracic, MD, from Ann & Robert H. Lurie Children’s Hospital of Chicago received $3 million from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) for a site-specific clinical trial on whether a soy supplement in infancy can prevent asthma in children with a high-risk genetic variation. This will be one of the earliest precision medicine approaches to asthma prevention.

“We will determine if we can decrease allergic airway inflammation in babies at risk of asthma and possibly prevent recurrent wheezing,” said Dr. Kumar, a physician in Allergy and Immunology at Lurie Children’s and Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “We will give babies a nutritional supplement from soy if they have a common genetic variation that promotes more allergic airway inflammation, especially around viral illness. This is important, since allergy and viral illness in early life dramatically increases the risk of asthma. We believe that interrupting allergic airway inflammation around viral illness in the first year of life may prevent progression to asthmatic type airway inflammation.”

Dr. Kumar’s previous research with his collaborator Seong Cho, MD, from the University of South Florida, found that asthma risk increased 17 times when children who had bronchiolitis in the first two years of life also had a common variation of the Plasminogen activator inhibitor-1 (PAI-1) gene. Similarly, children with this genetic variation were 12 times more likely to develop asthma after any lower respiratory tract infections requiring medical contact early in life (including those which were potentially less severe). Approximately 60 percent of the population has this genetic variation.

PAI-1 is a protein whose production increases in the airways in response to viral illness, potentially causing damage. The study found that by itself the variant of PAI-1 gene that produces more PAI-1 protein was not associated with a higher asthma risk. The risk of asthma and worse lung function increased only with the combination of the genetic variant and a severe viral respiratory illness early in life.

Previous lab-based research and human studies also found that soy isoflavones can decrease the product of the PAI-1 gene in blood, which leads Drs. Kumar, Pongracic and Cho to expect that soy isoflavones might be able to reduce allergic airway inflammation in young children with this genetic variation.

In the current study, soy isoflavones will be given as a supplement in a powder form mixed in either breast milk, formula, or water to infants 2-6 months old who are at high risk for developing asthma. Each infant will be enrolled for two years. Outcomes, such as airway inflammation and recurrent wheezing, will be compared against a placebo group.

“One of the most exciting aspects of our study is that the intervention does not require medication. We know that the soy supplement is safe, easy to consume and costs just pennies a day,” said Dr. Pongracic, Division Head of Allergy and Immunology at Lurie Children’s and Professor of Pediatrics at Northwestern University Feinberg School of Medicine.

The grant to Lurie Children’s is part of the NIAID funding to establish a nationwide clinical research network called Childhood Asthma in Urban Settings (CAUSE). Lurie Children’s is one of seven centers to participate.The CAUSE network extends and expands NIAID’s long-standing efforts to better understand and reduce the disproportionate burden of asthma among children living in low-income urban environments. Since 1991, NIAID has sponsored a series of research programs conducted in urban areas where pediatric asthma is prevalent and severe. Lurie Children’s has contributed to this research for the past 30 years.

“We are proud to continue to be part of these research efforts to help inner city children who are disproportionately affected by asthma,” said Dr. Pongracic. “Our collective research has truly moved the needle toward understanding asthma exacerbations and developing novel treatment strategies for these children.”

Among many accomplishments, NIAID-funded research found that exposure to cockroach allergen is a major risk factor for severe asthma in urban children and that programs to decrease exposures to cockroaches and other household allergens reduce children’s asthma symptoms and healthcare visits. Researchers also established that omalizumab, a drug that reduces immunoglobulin E, can prevent seasonal asthma attacks. In addition, scientists identified molecular pathways that evolve in the nasal passages of children with asthma who had colds that led to asthma attacks.

Research at Ann & Robert H. Lurie Children’s Hospital of Chicago is conducted through the Stanley Manne Children’s Research Institute. The Manne Research Institute is focused on improving child health, transforming pediatric medicine and ensuring healthier futures through the relentless pursuit of knowledge. Lurie Children’s is ranked as one of the nation’s top children’s hospitals by U.S. News & World Report. It is the pediatric training ground for Northwestern University Feinberg School of Medicine. Last year, the hospital served more than 220,000 children from 48 states and 49 countries.