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
39 weeks
Total Duration
On this page
Sponsors
R
Rajesh Kumar
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating soy isoflavones compared to a placebo in infants at risk of asthma who have a genetic variation causing higher levels of a pro-inflammatory protein called plasminogen activator inhibitor-1. The main goals are to see if soy isoflavones reduce the proportion of infants with a specific asthma-related immune profile (aT2 high endotype) by the end of treatment and to decrease wheezing episodes during the first year of life. This is a randomized, quadruple-masked, placebo-controlled clinical trial enrolling 65 high-risk infants under 12 months old with the PAI-1 risk genotype. Participants will be randomly assigned to receive either an oral soy isoflavone supplement or a matching placebo, both given twice daily mixed into a liquid or puree for 7 months. The dosing is similar to that found in soy formula, adjusted by age. The study includes a screening period with genotyping, a 7-month treatment period, and a 1-year observation period after treatment ends. Researchers will provide care for wheezing illnesses during the study and collect samples at specific visits. During participation, families will attend three in-person visits and six virtual visits in the first year, plus 11 monthly questionnaires and one in-person visit in the observation year. Samples collected include four nasal swabs, three blood draws, and four stool samples over the study. Infant lung function will be monitored overnight using a wearable device at key points. The main outcome measured is the T2 endotype from randomization to end of treatment, with secondary outcomes including wheezing episodes, expiratory variability index, and safety over the full study period.
CONDITIONS
Brief 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 is an adult (18 years or older) able to provide informed consent
- Infant is a term baby (born at or after 37 weeks gestation) less than 12 months old at recruitment
- High risk of asthma indicated by one or more of the following: parental history of asthma starting in childhood, parental asthma with other allergic conditions, or infant diagnosis of atopic dermatitis
- Infant carries the PAI-1 risk genotype (homozygous or heterozygous for 4G allele)
- Infant lives in specified recruitment areas or within the metropolitan area with publicly funded health insurance
You will not qualify if you...
- Parent or guardian unable or unwilling to provide consent or comply with the study
- Infant unable to take study product in puree or liquid form
- Infant currently receiving soy-based formula
- Breastfeeding mothers consuming soy supplements or soy-rich foods more than twice weekly and unwilling to stop
- Infant treated with regular inhaled steroids for wheezing
- Infant has known congenital thyroid disease or family history of estrogen-sensitive mutations
- Maternal use of tamoxifen during pregnancy or breastfeeding
- Use of immunomodulatory medications by mother while breastfeeding or by infant
- Use of other investigational agents within 30 days prior to randomization
- Caregiver with mental illness or substance abuse interfering with study compliance
- Known allergy to soy protein or NovaSoy
- Participation in other asthma-related studies recently
- Medical conditions or findings posing additional risk or interfering with study
- Infant requiring intubation before screening
- Infant with more than 3 hospitalizations for wheezing or asthma symptoms before screening
- Infant with more than 3 five-day oral steroid courses spaced 14 days apart before screening
- Chronic use of systemic corticosteroids or immunomodulators before or during study
- Inability or unwillingness to administer study medication or allow baseline measurements
- Infant living with foster parent as ward of state
- Caregiver lacks phone access
- Family plans to move away during study
- Primary caretaker does not speak English or Spanish
- At randomization: infant must be 4 to less than 12 months old, have PAI-1 risk genotype, and not have severe wheezing exacerbations or excessive steroid use between screening and randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 12 months
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for genotyping and eligibility assessment
Duration - Up to 12 months before randomization
Participants undergo a run-in period before randomization to confirm eligibility and prepare for treatment.
Visits as needed during screening and run-in combined
Duration - 7 months
Participants receive either soy isoflavone supplement or matching placebo twice daily for 7 months while monitored for wheezing illnesses and other health assessments.
6 virtual or in-person visits plus 1 in-person end of treatment visit, with additional in-person visits during viral illnesses
Duration - 1 year
Participants are observed for 1 year after the end of treatment to monitor health outcomes and lung function.
In-person visits at end of study and as needed for health assessments
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
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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