Soy Isoflavones for Inner City Infants at Risk for Asthma (SIRA)

As part of the NIAID-sponsored U01 Childhood Asthma in Urban Settings-Clinical Research Centers (CAUSE-CRC) network, the CAUSE-CRC investigators will conduct (1) multi-center observational studies and clinical trials through the network and (2) 1 small, center-specific single site project. The subcontract sites will work with the Lurie Children’s CAUSE-CRC to conduct the center-specific single site project. The proposed project will test the effects of soy isoflavone in infants at high risk to develop asthma. We will conduct a double-blind, two-arm, randomized, placebo-controlled trial to test whether administration of soy isoflavone to high-risk infants with the PAI-1 gain of function promoter genotype can decrease PAI-1 production in the airway during viral illness in early childhood, modulate development of T2 airway endotypes, reduce eosinophilic airway inflammation and decrease allergen sensitization. After screening and enrollment, infants will be randomized to 7 months of active treatment or placebo during the respiratory viral season in year 1, then followed for an additional observation year. During year 1, the children will be monitored by telephone every 4 weeks and they will come to the CRU during viral illnesses. During the observation year, they will be monitored by telephone. They will have a final visit, in-person at the end of the observation year.