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Clinical trialNCT05667701RecruitingPhase 2Interventional

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

SponsorRajesh KumarEnrollment65Asthma in ChildrenWheezing
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Rajesh Kumar, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Ann and Robert H Lurie Childrens Hospital of Chicago

    Chicago, Illinois, United States

    Abigail Lang, MDRajesh Kumar, MD
    Recruiting
  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Soy isoflavonesMatching placebo
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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
18 Sept 2024
Primary completion
31 Mar 2028
Completion
31 Dec 2028
Last update posted
21 Nov 2025
Registered enrollment
65
Registry id
NCT05667701

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.