Soy genistein supplements for infants at risk of asthma
Official title: Soy Isoflavones for Inner City Infants at Risk for Asthma (SIRA)
Funded at Lurie Children's Hospital of Chicago · NIH-11310166 · Data updated 2026-11-12
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
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Lurie Children's Hospital of Chicago NIH-funded |
| Lab location | 1 site (Chicago, United States) |
| Project start | April 14, 2021 |
| Project end | March 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $449,416 |
| NIH project number | 5U01AI160018-06 |
| Project ID | NIH-11310166 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
-
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
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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.