WheezingPhase 1/2GSVNCT07828405
Genes, Soy Isoflavones, and Virus
A Phase 1/2 study testing Soy Isoflavone Nutritional Supplements in people with Wheezing, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 24 months
- Conditions the study is for
- Wheezing
- What is being tested?
- Soy Isoflavone Nutritional Supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent or guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
- Age: Term infants (≥37 weeks) aged 4 months to 24 months at recruitment.
- Admitted to Lurie Children's Hospital or presenting to ED for an acute viral lower respiratory tract infection within 1-3 days of onset.
Who cannot join
- Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol
- Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water)
- Currently on a soy based formula as determined by the judgement of the study investigators
- 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.
- On provider prescribed treatment for recurrent wheezing such as regular or intermittent inhaled steroids
- The infant may not have the following specific contraindications: known congenital thyroid disease, or a history of estrogen sensitive clinically relevant mutations in the family (such as BRCA1).
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- Medication use:
- Maternal use of tamoxifen during pregnancy or breastfeeding
- Use of immunomodulatory medications such as methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.
- Use of another investigational agent in the last 30 days prior
- 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
- 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.
- 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
- 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.
- Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent prior to visit 1 (V1).
- Non-adherence:
- Inability / unwillingness of the parents to facilitate ingestion of the investigational product
- Unwillingness of the parents to allow the staff to perform baseline procedures of nasal swabs
- Participant is in foster care or is a ward of the state.
- Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires)
- Plan(s) for the family to move from the area during the study period
- The infant's caretaker does not primarily speak English or Spanish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ann & Robert H Lurie Children's hospital of Chicago
Chicago, Illinois, 60311
Caroline Merck, MS, 312-227-2469, cmerck@luriechildrens.org
Aliviya Schulze, BS, 312-227-5391, aschulze@luriechildrens.org
About this study
Official title: Genes, Soy Isoflavones, and Virus - Preventing Airway Remodeling, Asthma, and Wheezing Study
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.
- Conditions
- Wheezing
- Being tested
- Soy Isoflavone Nutritional Supplements
- Keywords
- soy isoflavone, PAI-1
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy Isoflavone Nutritional SupplementsDrug
Soy isoflavone will be administered orally at a dose of 1.5 mg/ kg divided bid from presentation to day 7 of illness
| Study group | Role | What they receive |
|---|---|---|
| soy isoflavone | Experimental | soy isoflavone at 1.5 mg/kg divided bid dosed from presentation for 2 - 3 day sof dosing Receives: Drug: Soy Isoflavone Nutritional Supplements |
| observational arm for more severe subjects | No intervention | these subjects will have endotyping carried out by nasal swab at presentation and day 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eos3 transcriptional module expression
The mean expression level of the Th2 and ciliated epithelium (eos3) transcriptional module at day 4-7 of viral illness
Measured: 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
Measured: day 4-7 of illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study will administer soy isoflavone till day 7 of illness in an unblinded manner to milder subjects who present to the ED within 1-3 days of onset of wheezing illness. Those who are more severe will serve as a control arm and have standard of care treatment. Both groups have initial and followup swabs carried out for endotyping at days 4-7.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajesh Kumar, MD, MSCI, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828405
- Sponsor's protocol ID
- STUDY00001088
- Acronym
- GSV
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request after publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genes, Soy Isoflavones, and Virus - Preventing Airway Remodeling, Asthma, and Wheezing Study
- ClinicalTrials.gov ID
- NCT07828405
- Acronym / sponsor ID
- GSV / STUDY00001088
- Conditions
- Wheezing
- Keywords
- soy isoflavone, PAI-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will administer soy isoflavone till day 7 of illness in an unblinded manner to milder subjects who present to the ED within 1-3 days of onset of wheezing illness. Those who are more severe will serve as a control arm and have standard of care treatment. Both groups have initial and followup swabs carried out for endotyping at days 4-7.
| Arm | Type | Receives |
|---|---|---|
| soy isoflavone | Experimental | Drug: Soy Isoflavone Nutritional Supplementssoy isoflavone at 1.5 mg/kg divided bid dosed from presentation for 2 - 3 day sof dosing |
| observational arm for more severe subjects | No intervention | –these subjects will have endotyping carried out by nasal swab at presentation and day 7 |
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent or guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
- Age: Term infants (≥37 weeks) aged 4 months to 24 months at recruitment.
- Admitted to Lurie Children's Hospital or presenting to ED for an acute viral lower respiratory tract infection within 1-3 days of onset.
Key exclusion criteria (22 listed)
- Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol
- Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water)
- Currently on a soy based formula as determined by the judgement of the study investigators
- 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.
- On provider prescribed treatment for recurrent wheezing such as regular or intermittent inhaled steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy Isoflavone Nutritional SupplementsSoy isoflavone will be administered orally at a dose of 1.5 mg/ kg divided bid from presentation to day 7 of illness | Drug | soy isoflavone |
Primary outcome
Eos3 transcriptional module expression
Time frame: on day 4-7 of illness after 2-3 days of dosing
The mean expression level of the Th2 and ciliated epithelium (eos3) transcriptional module at day 4-7 of viral illness
1 secondary outcome
Th2 and epithelial module expression
Time frame: day 4-7 of illness
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be available on request after publication.
Related trials for Wheezing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Kumar, MD, MSCI principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Soy Isoflavone Nutritional Supplements in people with Wheezing, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Merck, MPH (312-227-2469, cmerck@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eos3 transcriptional module expression (time frame: on day 4-7 of illness after 2-3 days of dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.