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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rajesh Kumar
Study ID
NCT05667701
Phase
PHASE2
Status
Recruiting
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Conditions

  • Asthma in Children
  • Wheezing

Eligibility Criteria

Sex
ALL
Age
2 Months - 12 Months
Healthy Volunteers
Accepted

Interventions

  • Soy isoflavone — DRUG
    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
  • matching placebo — DRUG
    A matching placebo also administered twice daily.

Study Details

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 Dates

Start date
Sep 18, 2024
Status verified
Nov 2025
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Soy isoflavone
    Soy isoflavone powder dosed in puree or liquid twice daily
  • Placebo Comparator: Placebo
    Matching placebo powder dosed in puree or liquid twice daily

Primary Outcome Measure

T2 endotype [ Time Frame: From week 0 (randomization) to week 30 (end of treatment) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ann and Robert H Lurie Childrens Hospital of ChicagoChicagoIllinois60611
Rajesh Kumar, MD
312 227 6010
Rajesh Kumar, MD (PRINCIPAL_INVESTIGATOR)
Abigail Lang, MD (SUB_INVESTIGATOR)
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Michelle Kominarek, MD

Find similar trials in Chicago, IL

By research site
Ann and Robert H Lurie Childrens Hospital of Chicago· Chicago, ILNorthwestern University Feinberg School of Medicine· Chicago, IL

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