Genes, Soy Isoflavones, and Virus

NCT07828405 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY00001088
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wheezing

Keywords

soy isoflavone; PAI-1

Outcome Measures

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

  on day 4-7 of illness after 2-3 days of dosing

Secondary Outcomes (1)

• Th2 and epithelial module expression

  day 4-7 of illness

Study Arms (2)

soy isoflavone

EXPERIMENTAL

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

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

Interventions

Soy Isoflavone Nutritional Supplements DRUG

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

soy isoflavone

Eligibility Criteria

• Age: 4 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).
• 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:

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's hospital of Chicago

Chicago, Illinois, 60311, United States

Location

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajesh Kumar, MD, MSCI

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Merck, MPH

CONTACT

312-227-2469; cmerck@luriechildrens.org

Aliviya Schulze, BS

CONTACT

312-227-5391; aschulze@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)