NCT05667701

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Rajesh Kumar · Academic / Other
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Accepted

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.

Detailed description

The study is designed as a single site, randomized, quadruple-masked, placebo-controlled, parallel group clinical trial. We will enroll 65 high risk infants with the PAI-1 risk genotype, who are less than 12 months of age, and will be randomized to one of two treatment groups. The treatment groups will be either oral isoflavone supplement (at doses similar to that seen in soy formula) or a matching placebo . Screening will occur throughout each year, with genotyping occurring at the first visit, and assumption of care of individuals with the risk genotype after randomization. There will be a study run in period up to 12 months at which time subjects will be randomized. The treatment period will run for 7 months for each participant, and will have a 1 year observation period after the end of treatment. At randomization, the investigators will assume the care of the children for all wheezing illnesses. The subjects will have either virtual or in person visits for each of the next 6 visits, followed by an in-person visit at the end of treatment. The subjects will also come in for in-person visits at times of viral illnesses. At randomization, end of treatment, viral illness, and end of study the subjects will have nasal swabs and nasosorption carried out. Blood draws will occur at randomization, end of treatment, and the end of study visit. Stool will be collected for microbiome assessment at randomization, the 3rd or 4th month of treatment, the end of treatment, and the end of the study at the end of the observation year. The study will also measure infant pulmonary function using a wearable device to assess expiratory variability overnight. This will be measured at randomization, viral illness, end of treatment, and at the end of the study after the 1 year observation period. The treatment period will run for 7 months for each participant, with a 1 year observation period after this.

Conditions

• Wheezing
• Asthma in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-18
• Primary completion: 2028-03-31
• Completion: 2028-12-31
• First posted: 2022-12-29
• Last updated: 2025-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study