ClinicalTrials.gg
Not yet recruitingNCT07828405GSVUpdated Sep 18, 2026

Genes, Soy Isoflavones, and Virus

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
4 Months to 24 Months
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Wheezing

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Keywords

  • soy isoflavone
  • PAI-1
03

In context

Respiratory Sounds

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Parent or guardian must be an adult (≥18 years of age) and able to understand and provide .
  2. Age: Term infants (≥37 weeks) aged 4 months to 24 months at recruitment.
  3. Admitted to Lurie Children's Hospital or presenting to ED for an acute viral lower respiratory tract infection within 1-3 days of onset.

Exclusion criteria

Exclusion Criteria:

  1. Inability or unwillingness of a parent or guardian to give written or comply with study protocol
  2. Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water)
  3. Currently on a soy based formula as determined by the judgement of the study investigators
  4. Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding (assessed by soy intake questionnaire). Note there is no coercion to change dietary practices. This is simply an exclusion criteria if the mother does not want to limit soy intake to this level for the time of the study.
  5. On provider prescribed treatment for recurrent wheezing such as regular or intermittent inhaled
  6. The infant may not have the following specific : known congenital thyroid disease, or a history of estrogen sensitive mutations in the family (such as BRCA1).
  7. Medication use:

    1. Maternal use of tamoxifen during pregnancy or breastfeeding
    2. Use of immunomodulatory medications such as methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.
  8. Use of another investigational agent in the last 30 days prior
  9. Current parent reported diagnosis of mental illness or current self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
  10. Known allergy to soy protein (either by reported allergy or prior positive allergy results and no history of ongoing ingestion) or reported allergy to NovaSoyTM, from which the investigational product is compounded.
  11. The infant is currently participating in another allergic disease (asthma, food allergy, or AD) -related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to enrollment
  12. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
  13. Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent prior to visit 1 (V1).
  14. Non-adherence:

    1. Inability / unwillingness of the parents to facilitate ingestion of the investigational product
    2. Unwillingness of the parents to allow the staff to perform baseline procedures of nasal swabs
  15. Participant is in foster care or is a ward of the state.
  16. Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires)
  17. Plan(s) for the family to move from the area during the study period
  18. The infant's caretaker does not primarily speak English or Spanish.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    soy isoflavone

    soy isoflavone at 1.5 mg/kg divided bid dosed from presentation for 2 - 3 day sof dosing

    Drug: Soy Isoflavone Nutritional Supplements

  • No intervention
    observational arm for more severe subjects

    these subjects will have endotyping carried out by nasal swab at presentation and day 7

Interventions

  • DrugSoy Isoflavone Nutritional Supplements

    Soy isoflavone will be administered orally at a dose of 1.5 mg/ kg divided bid from presentation to day 7 of illness

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 18, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07828405
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Sep 18, 2026

Study contacts

Caroline Merck, MPH
Contact
cmerck@luriechildrens.org
312-227-2469
Aliviya Schulze, BS
Contact
aschulze@luriechildrens.org
312-227-5391
Rajesh Kumar, MD, MSCI
principal investigator · Ann & Robert H Lurie Children's Hospital of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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