RecruitingPhase 2NCT05667701

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

Sponsor

Rajesh Kumar

Enrollment

65 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Asthma in Children Wheezing

Summary

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.

Eligibility

Min Age: 2 MonthsMax Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This study looks at whether soy isoflavones — plant-based compounds found in soy — given in early infancy can reduce the risk of developing asthma in children who are at high risk, particularly those from inner-city environments. **You may be eligible if...** - Your baby was born at term (at least 37 weeks) and is under 12 months old - One or both parents have asthma, especially childhood-onset asthma - Your baby has risk factors for asthma, such as family history of allergies (hay fever, eczema, or food allergy) - The parent or guardian is an adult (18+) who can provide consent **You may NOT be eligible if...** - Your baby was born prematurely (before 37 weeks) - Your baby already has a diagnosis of asthma or is on asthma medications - There is a known allergy to soy - Your baby has serious existing health problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSoy 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

DRUGmatching placebo

A matching placebo also administered twice daily.