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.

NCT05667701

Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

Recruiting
PHASE2Ages 2–12InterventionalTreatment
Rajesh Kumar
~65 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:Soy isoflavonematching placebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
T2 endotype
Measured over From week 0 (randomization) to week 30 (end of treatment)
Wheezing
Asthma in Children
2 sites across 1 states
Illinois2
  • Rajesh Kumar, MD · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago

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  • 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.