Genes, Soy Isoflavones, and Virus

Prior treatment

• Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water)
• Currently on a soy based formula as determined by the judgement of the study investigators
• On provider prescribed treatment for recurrent wheezing such as regular or intermittent inhaled steroids
• Medication use:
  • Maternal use of tamoxifen during pregnancy or breastfeeding
  • Use of immunomodulatory medications such as methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.
• Use of another investigational agent in the last 30 days prior
• Known allergy to soy protein (either by reported allergy or prior positive allergy results and no history of ongoing ingestion) or reported allergy to NovaSoyTM, from which the investigational product is compounded.
• The infant is currently participating in another allergic disease (asthma, food allergy, or AD) -related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to enrollment
• Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent prior to visit 1 (V1).
• Non-adherence:
  • Inability / unwillingness of the parents to facilitate ingestion of the investigational product
  • Unwillingness of the parents to allow the staff to perform baseline procedures of nasal swabs

Other illness

• The infant may not have the following specific contraindications: known congenital thyroid disease, or a history of estrogen sensitive clinically relevant mutations in the family (such as BRCA1).
• Current parent reported diagnosis of mental illness or current self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements

Lab values

• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Other

• Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol
• Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding (assessed by soy intake questionnaire). Note there is no coercion to change dietary practices. This is simply an exclusion criteria if the mother does not want to limit soy intake to this level for the time of the study.
• Participant is in foster care or is a ward of the state.
• Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires)
• Plan(s) for the family to move from the area during the study period
• The infant's caretaker does not primarily speak English or Spanish.

• Parent or guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
• Age: Term infants (≥37 weeks) aged 4 months to 24 months at recruitment.
• Admitted to Lurie Children's Hospital or presenting to ED for an acute viral lower respiratory tract infection within 1-3 days of onset.