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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Soy isoflavone
DrugSoy 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
DrugA matching placebo also administered twice daily.
Treatment groups
65 Participants
are divided into 2 treatment groupsGroup A: Soy isoflavoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
T2 endotype
This measure is determined by the proportion of subjects designated as having a T2 high endotype at the end of the treatment period (week 32) in the soy genistein vs placebo treatment arms.
Time frame
From week 0 (randomization) to week 30 (end of treatment)Secondary outcomes
1
wheezing episodes
Number of episodes of wheezing - based on numbers of reported episodes of illness associated with wheezing over the treatment period.
Time frame
7 months2
Expiratory variability index
Infant pulmonary function assessed by measurement of the Expiratory Variability Index change from baseline
Time frame
from week 0 (randomization) to week 30 (end of treatment) and from week 0 (randomization) to week 88 (end of study)3
safety and tolerability
Number and grade of adverse events by treatment arm
Time frame
from week 0 (randomization) to week 88 (end of study)Other outcomes
1
Other measures of wheezing and respiratory morbidity
modified asthma predictive index at the end of the study
Time frame
week 88 - end of study visit2
sensitization to allergens
The proportion of participants sensitized to indoor allergens (assessed by measurement of Dermatophygoides farinae, Dermatophygoides pteronyssinius, dog, cat, cockroach, mouse sIgE) and food allergens (milk, egg, peanut, wheat, and soy)
Time frame
Week 30 at the end of treatment3
work disruption due to child's asthma
The ratio of the work hours missed due to child's asthma over the numbers of work hours in the past 14 days in active vs placebo groups at each visit.
Time frame
Week 0 to week 304
Daycare/ pre-school Absences due to the child's asthma
The ratio of the number of school days missed over the number of school days in session in active vs placebo participants
Time frame
from randomization (week 0) to the end of treatment (week 30) and secondarily to the end of the observation period (week 88)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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