Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
Status:
Not yet recruiting
Trial end date:
2028-09-30
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 2
Details
Lead Sponsor:
Rajesh Kumar
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID) Northwestern University University of Colorado, Denver University of South Florida