A Phase 1/2 interventional study of Soy Isoflavone Nutritional Supplements in Wheezing, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Not yet recruiting at 1 site in United States. Open to participants aged 4 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Phase 1/2, Interventional, and Treatment
In this study, we will assess whether children without established asthma who have a variation in the switch for the PAI-1 gene will have higher PAI-1 levels and remodeling / allergic inflammatory pathways in their airways than children who do not have the gene. We will also determine if soy isoflavones given when presenting for an acute respiratory illness can decrease these changes.
Pediatric asthma affects 8.3% of U.S. children, accounting for 5.92 billion dollars of U.S. health care expenditure annually. Approximately 80% of the children who progress to have asthma will have wheeze in early childhood, suggesting that primary prevention should target infancy. In particular, severe early life viral lower respiratory tract infection (LRTI) shows strong associations with asthma development which are modified by genetic predisposition.1-5 A gain of function plasminogen activator inhibitor-1 (PAI-1) promoter variant is present in up to 60% of the population who develop asthma in either homozygote or heterozygote form. If children with ≥1 copy of the PAI-1 risk allele had a respiratory viral illness requiring a physician visit before 2 years old, these subjects had a 12-fold (any virus) to 18-fold (self-reported Respiratory Syncytial Virus (RSV)) increased risk of developing asthma. PAI-1 production increases in the airway at the time of a viral illness and promotes both fibrosis and an allergic airway milieu. We have found that soy isoflavones decrease the production of PAI-1 and decrease rates of asthma exacerbations by 75% in subjects with the risk gene. This pilot will allow for preliminary data to determine if on-demand treatment with soy isoflavone improves epithelial integrity and decreases Th2 airway responses if dosed with onset of illness. This would establish the viability of on demand treatment for early life viral illness which may modulate acute outcomes. In this study, we will assess whether children without established asthma who have the PAI-1 genotype will have higher PAI-1 levels and remodeling / allergic inflammatory pathways in their airways than children who do not have the genotype. We will also determine if soy isoflavones given when presenting for an acute respiratory illness can decrease these changes in children both with and without the genotype. Finally, we will also study these questions in a lung organoid / Air Liquid Interface (ALI) model with cells from subjects with the risk allele, which will allow us to compare soy isoflavone pre-inoculation treatment with treatment post infection in a controlled experiment. These data would be essential to set up the team to assess the effects of on demand treatment of children with LRTI irrespective of asthma after presentation to the ED. This would be an important step forward compared to chronic treatment in high-risk populations which will have barriers to implementation.
189 studies on the registry are indexed under Respiratory Sounds; 41 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 98 interventional studies indexed under Respiratory Sounds.
Browse Respiratory Sounds studies →Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 180 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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soy isoflavone at 1.5 mg/kg divided bid dosed from presentation for 2 - 3 day sof dosing
Drug: Soy Isoflavone Nutritional Supplements
these subjects will have endotyping carried out by nasal swab at presentation and day 7
Soy isoflavone will be administered orally at a dose of 1.5 mg/ kg divided bid from presentation to day 7 of illness
Eos3 transcriptional module expression
The mean expression level of the Th2 and ciliated epithelium (eos3) transcriptional module at day 4-7 of viral illness
Time frame: on day 4-7 of illness after 2-3 days of dosing
Th2 and epithelial module expression
This will include the mean expression level of other key transcriptional modules representing Th2 and epithelial processes, including expression of m24\<squamous epithelium\>, squa1 \<tight junctions and epithelial integrity\>, and m27 \<TGFB/SMAD3 regulation of PAI-1\> modules at day 4-7 of viral illness of viral illness
Time frame: day 4-7 of illness
Plan to share: Yes — Data will be available on request after publication.
Supporting information: Study protocol
Time frame: de-identified data will be available after study close.
Access criteria: all investigators who request access after publication of findings will have a deidentified dataset shared with them
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
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