NCT05667701 · Rajesh Kumar
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
(SIRA)
What this study is about
The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1.
View original scientific description
The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1.
Interventions
DRUG
Soy isoflavone
Soy isoflavone supplement (Novasoy) that contains isoflavones (genistein, daidzein, glycetein) given at a dose of genistein aglycone equivalents to provide the genistein dosing of 22.6 mg/day for children aged 2-10 months, and 30.3 mg/day children aged 10-24 months
DRUG
matching placebo
A matching placebo also administered twice daily.
Primary outcome measures
T2 endotype
Time frame: From week 0 (randomization) to week 30 (end of treatment)
This measure is determined by the proportion of subjects designated as having a T2 high endotype at the end of the treatment period (week 32) in the soy genistein vs placebo treatment arms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Parent guardian must be able to understand and provide informed consent. 2. Age: Term children (≥37 weeks gestational age) born from January 1 to May 15 of the recruitment year. 3. High risk of asthma: As determined by one or more of the following: 1. A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR 2. Uni- or bi-parental asthma with onset after childhood along with the presence of one or more other comorbid atopic condition including allergic rhinitis, atopic dermatitis, or food allergy, OR 3. atopic dermatitis in the child determined by parent report of a physician diagnosis 4. Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).
Exclusion criteria
- Inability or unwillingness of a parent guardian to give written informed consent 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 ab
Where
- Chicago, Illinois
Collaborators
Northwestern University, University of South Florida, University of Colorado, Denver, National Institute of Allergy and Infectious Diseases (NIAID)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations