Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-12
SponsorRajesh Kumar
About this trial
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 criteria
Qualifiers
Parent/guardian must be an adult (≥18 years of age) and able to understand and provide informed consent.
Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment
A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR
Uni- or bi-parental asthma with onset after childhood along with the presence of one or more other comorbid atopic condition including allergic rhinitis, atopic dermatitis, or food allergy, OR
Disqualifiers
1. Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol.
Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water).
Currently on a soy based formula.
Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding.
Trial design
Treatments tested in this trial
- Soy isoflavone
- matching placebo
Treatment groups
65 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rajesh Kumar
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
Northwestern University
Collaborator
University of South Florida
Collaborator
University of Colorado, Denver
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov