Genes, Soy Isoflavones, and Virus

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT07828405
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Wheezing

Eligibility Criteria

Sex
ALL
Age
4 Months - 24 Months
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Sep 18, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: soy isoflavone
    soy isoflavone at 1.5 mg/kg divided bid dosed from presentation for 2 - 3 day sof dosing
  • No Intervention: observational arm for more severe subjects
    these subjects will have endotyping carried out by nasal swab at presentation and day 7

Primary Outcome Measure

Eos3 transcriptional module expression [ Time Frame: on day 4-7 of illness after 2-3 days of dosing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H Lurie Children's hospital of ChicagoChicagoIllinois60311
Caroline Merck, MS
[email protected]
312-227-2469
Aliviya Schulze, BS
[email protected]
312-227-5391

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By research site
Ann & Robert H Lurie Children's hospital of Chicago· Chicago, IL

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