Soy genistein supplements for infants at risk of asthma
Soy Isoflavones for Inner City Infants at Risk for Asthma (SIRA)
['FUNDING_U01'] · LURIE CHILDREN'S HOSPITAL OF CHICAGO · NIH-11310166
Researchers will give a soy compound called genistein or a placebo to infants who carry a common PAI‑1 gene variant and are at high risk for asthma to try to lower their chance of developing asthma.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | LURIE CHILDREN'S HOSPITAL OF CHICAGO (nih funded) |
| Locations | 1 site (CHICAGO, UNITED STATES) |
| Trial ID | NIH-11310166 on ClinicalTrials.gov |
What this research studies
If your baby carries a common PAI‑1 gene change linked to higher asthma risk, this trial will randomly give them either a soy-based genistein supplement or a placebo during the first year of life. The trial is quadruple-masked and conducted at Lurie Children's Hospital in Chicago, with doses chosen to match amounts in soy formula. Doctors will follow infants with clinic visits and lab tests to measure immune markers such as IgE, interferon responses, and signs of Th2 airway inflammation and allergic sensitization. The aim is to see whether early genistein exposure changes immune responses and lowers the likelihood of developing asthma.
Who could benefit from this research
Good fit: Ideal candidates are inner-city infants in their first year of life who carry the PAI‑1 gain-of-function variant that is linked to higher asthma risk.
Not a fit: Older children, people without the PAI‑1 risk variant, infants already diagnosed with asthma, or those with soy allergy are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lower allergic inflammation and reduce the chance that high-risk infants go on to develop asthma.
How similar studies have performed: Prior work showed soy isoflavones reduced asthma exacerbations by a large amount in people with the PAI‑1 genotype, but giving genistein to infants to prevent asthma is a new preventive approach.
Where this research is happening
CHICAGO, UNITED STATES
- LURIE CHILDREN'S HOSPITAL OF CHICAGO — CHICAGO, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: KUMAR, RAJESH — LURIE CHILDREN'S HOSPITAL OF CHICAGO
- Study coordinator: KUMAR, RAJESH
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.