Soy Isoflavones for Infants at Risk of Asthma
This study is testing whether a soy isoflavone supplement (Novasoy) can help infants at high risk for asthma. We're looking for babies between 2 and 12 months old who have a specific genetic variation that makes them produce more of a protein called plasminogen activator inhibitor-1 (PAI-1), which can cause inflammation. Participants will receive either the soy isoflavone supplement or a matching placebo (an inactive substance) twice daily for 7 months. The main goal is to see if the soy isoflavones can reduce the number of infants with a specific type of asthma (T2 high endotype) and also decrease wheezing episodes. The study is currently unclear on its recruitment status.
- Study design
- This is a randomized, quadruple-masked, placebo-controlled study involving 65 infants. Participants will be assigned by chance to receive either the soy isoflavone supplement or a placebo, and neither you nor the study team will know which one you are receiving.
- What's involved
- Participants will take a supplement twice daily for 7 months. There will be 3 required in-person visits and 6 virtual visits in the first year, plus additional in-person visits if your child has a viral illness.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 7-month treatment period, there will be a 1-year observation period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Rajesh Kumar, MD · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- T2 endotypeFrom week 0 (randomization) to week 30 (end of treatment)
This measure is determined by the proportion of subjects designated as having a T2 high endotype at the end of the treatment period (week 32) in the soy genistein vs placebo treatment arms.