Wheezing study: Soy isoflavone
Official title Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
ClinicalTrials.gov ID: NCT05667701
What this study is testing
What is Soy isoflavone (Novasoy)?
an investigational soy isoflavone supplement being studied as a potential treatment to reduce wheezing in high‑risk infants
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if soy isoflavones (plant compounds) reduce asthma risk and wheezing in infants with a gene that causes extra inflammation.
- Who it's for
- Babies at risk for asthma who have a specific genetic variation that leads to higher levels of an inflammatory protein.
- What's involved
- Participants take soy or a fake supplement twice daily mixed into food. They also provide nasal swabs, blood samples, and stool samples.
- Time commitment
- The study lasts about two years, involving 9 in-person visits, 6 virtual visits, and monthly questionnaires.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 12. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- atopic dermatitis in the child determined by parent report of a physician diagnosis
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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
- 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).
- Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for...
What rules you out
- 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...
- 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
- Use of immunomodulatory medications such at methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant.
- Use of another investigational agent in the last 30 days prior to randomization.
- Current, parent reported, diagnosis of mental illness or current, diagnosed or self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the...
- Known allergy to soy protein (either by reported allergy or skin testing to soy prior to randomization) or reported allergy to NovaSoy, from which the investigational product is compounded.
- The infant is currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior...
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Infant requiring intubation prior to screening.
- Infant requiring \> 3 hospitalizations for asthma symptoms/ wheezing illness prior to screening.
- Infant requiring \> 3 five day bursts of oral steroid at least 14 days apart from each other prior to screening.
- Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent at screening or before randomization, and during the course of the study.
- Inability / unwillingness of the parents to induce the infant to swallow study medication
- Unwillingness of the parents to allow the staff to perform baseline measurements
- Living with a foster parent as a ward of the state.
- Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires).
- Plan(s) for the family to move from the area during the study period.
- Must be ≥4 months and \<12 months of age at randomization
- Must have either 4G/4G or 4G/5G genotype
- Cannot have had a severe wheezing exacerbation requiring ICU admission between screening (V1) and randomization (V3)
- Cannot have had more than two wheezing / "asthma" episodes (separated from each other by at least 14 days), each requiring at least a 5 day course of oral steroids in the time between screening visit A (V1) and...
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months to 12 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.