Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Wheezing, Asthma in Children

In brief

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.

Key facts

Study ID

NCT05667701

Run by

Rajesh Kumar

People needed

65

Starts

2024-09-18

Expected to finish

2028-12-31

Last updated by the study team

2025-11-21

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Parent/guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
• Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment
• High risk of asthma: As determined by one or more of the following:
• A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR
• 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
• atopic dermatitis in the child determined by parent report of a physician diagnosis
• Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).
• Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the SIRA Manual of Operations (MOP).
• Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion.

You may not qualify if…

• 1. 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.
• Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding.
• On treatment for recurrent wheezing such as regular 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 in pregnancy or if breastfeeding
• Use of immunomodulatory medications such at 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 to randomization.
• Current, parent reported, diagnosis of mental illness or current, diagnosed or 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 skin testing to soy prior to randomization) or reported allergy to NovaSoy, from which the investigational product is compounded.
• The infant is currently participating in another asthma-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.
• Infant requiring intubation prior to screening.
• Infant requiring > 3 hospitalizations for asthma symptoms/ wheezing illness prior to screening.
• Infant requiring > 3 five day bursts of oral steroid at least 14 days apart from each other prior to screening.
• Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent at screening or before randomization, and during the course of the study.
• Non-adherence:
• Inability / unwillingness of the parents to induce the infant to swallow study medication
• Unwillingness of the parents to allow the staff to perform baseline measurements
• Living with a foster parent as a ward of the state.
• Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires).
• Plan(s) for the family to move from the area during the study period.
• The infant's caretaker does not primarily speak English or Spanish.

Where it is running

• Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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