Actively Recruiting
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
Led by Rajesh Kumar · Updated on 2025-11-21
65
Participants Needed
2
Research Sites
223 weeks
Total Duration
On this page
Sponsors
R
Rajesh Kumar
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial 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. The main questions this trail seeks to answer is: will soy isoflavones decrease the proportion of infants with aT2 high endotype at the end of treatment, and secondarily decrease the number of wheezing episodes in these children when given in the first year of life. Participants will be asked to ingest soy isoflavone or placebo twice daily mixed into a liquid or puree vehicle for 7 months from randomization. There will be 3 mandatory in-person visits, and 6 virtual visits in the first year. There will also be 11 monthly questionnaires and 1 in person visit in the observation year. Participants will have 4 nasal swabs, 3 blood draws, and also provide 4 stool samples over the course of the study.
CONDITIONS
Official Title
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or guardian must be an adult (18 years or older) able to provide informed consent
- Infant less than 12 months old and born at or after 37 weeks gestation
- High risk of asthma defined by: parent asthma history starting in childhood, or parent asthma after childhood with other allergic conditions, or the infant has doctor-diagnosed atopic dermatitis
- Infant has the PAI-1 risk genotype (4G4G or 4G5G)
- Infant lives in specified census tracts or within the metropolitan area with public health insurance
You will not qualify if you...
- Parent or guardian unwilling or unable to provide consent or follow the study protocol
- Infant cannot take the study product in liquid or puree form
- Infant currently on soy-based formula
- Breastfeeding mother consumes soy supplements or soy foods more than twice weekly and will not stop
- Infant receiving regular inhaled steroids for wheezing
- Infant has known congenital thyroid disease or family history of estrogen-sensitive mutations like BRCA1
- Maternal use of tamoxifen during pregnancy or breastfeeding
- Use of immunomodulatory drugs by mother while breastfeeding or infant
- Use of other investigational agents within 30 days before randomization
- Caregiver has diagnosed or suspected mental illness or substance abuse impacting study compliance
- Known soy allergy or allergy to NovaSoy
- Participation in other asthma-related intervention studies recently
- Infant has medical conditions posing risks or interfering with study
- Infant required intubation before screening
- Infant had more than 3 hospitalizations or oral steroid bursts for wheezing before screening
- Use of systemic corticosteroids or immunomodulators at or before screening
- Parent unwilling to give study medication or allow baseline measurements
- Infant is a ward of the state living with foster parents
- Caregiver lacks phone access
- Family plans to move during study
- Caregiver does not primarily speak English or Spanish
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Sarah Godley, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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