Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study (NCT05667701) | Clinical Trial Compass
RecruitingPhase 2
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
United States65 participantsStarted 2024-09-18
Plain-language 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 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.
Who can participate
Age range2 Months – 12 Months
SexALL
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Inclusion criteria
✓. 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
✓. High risk of asthma: As determined by one or more of the following:
✓. 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
✓. atopic dermatitis in the child determined by parent report of a physician diagnosis
✓. Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G).
✓. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the SIRA Manual of Operations (MOP).
Exclusion criteria
What they're measuring
1
T2 endotype
Timeframe: From week 0 (randomization) to week 30 (end of treatment)
. 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.
✕. On treatment for recurrent wheezing such as regular inhaled steroids.
✕. The infant may not have the following specific contraindications: known congenital thyroid disease, or a history of estrogen sensitive clinically relevant mutations in the family (such as BRCA1).
✕. Medication use
✕. Maternal use of tamoxifen in pregnancy or if breastfeeding