Genes, Soy Isoflavones, and Virus
Genes, Soy Isoflavones, and Virus - Preventing Airway Remodeling, Asthma, and Wheezing Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 4 Months to 24 Months
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at whether a change in the PAI-1 gene's control switch is linked to higher PAI-1 levels, airway changes, and allergy-related swelling. It also tests whether soy compounds called isoflavones can reduce these changes during a sudden breathing illness. It is for children ages 4 to 24 months who were born at full term and do not have established asthma.
In this study, we will assess whether children without established asthma who have a variation in the switch for the PAI-1 gene will have higher PAI-1 levels and remodeling / allergic inflammatory pathways in their airways than children who do not have the gene. We will also determine if soy isoflavones given when presenting for an acute respiratory illness can decrease these changes.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- The parent or guardian is at least 18 and can understand and give consent for the child to join.
- The child is 4 to 24 months old and was born at 37 weeks of pregnancy or later.
- The child is admitted to Lurie Children's Hospital or comes to its emergency department for a viral infection in the lungs or lower airways, within 1 to 3 days after symptoms start.
Who can't join
- The parent or guardian cannot or will not give written consent, follow study steps, give the study product in pureed food or bottle-fed liquid, or allow the first nose swabs.
- The child uses soy formula or has a known soy protein allergy or reported NovaSoy allergy. A breastfeeding mother eats soy-enriched foods or takes soy supplements more than twice a week and does not want to limit this during the study.
- The child gets prescribed treatment for repeated wheezing, such as inhaled steroids, or has a long-term condition requiring steroids that affect the whole body or other drugs that change immune activity before the first visit.
- The child has thyroid disease present at birth, or the family has a history of important gene changes sensitive to estrogen, a hormone, such as BRCA1. Other health problems or test findings may also rule out joining if the study doctor thinks they could affect safety, study steps, or results.
- The mother used tamoxifen during pregnancy or breastfeeding. The child, or the mother while breastfeeding, uses drugs that change immune activity, such as methotrexate, mycophenolate, or azathioprine.
- The child used another experimental treatment in the past 30 days, is in another allergy-related drug or treatment study, or was in an asthma-related drug or treatment study in the month before joining.
- The main caregiver reports a current mental illness or drug or alcohol abuse that the study doctor thinks would make it hard to follow study steps.
- The child is in foster care or state care. The caregiver has no phone, the family plans to move away during the study, or the child's caregiver does not mainly speak English or Spanish.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Parent or guardian must be an adult (≥18 years of age) and able to understand and provide informed consent. 2. Age: Term infants (≥37 weeks) aged 4 months to 24 months at recruitment. 3. Admitted to Lurie Children's Hospital or presenting to ED for an acute viral lower respiratory tract infection within 1-3 days of onset. Exclusion Criteria: 1. Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol 2. 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) 3. Currently on a soy based formula as determined by the judgement of the study investigators 4. 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 (assessed by soy intake questionnaire). Note there is no coercion to change dietary practices. This is simply an exclusion criteria if the mother does not want to limit soy intake to this level for the time of the study. 5. On provider prescribed treatment for recurrent wheezing such as regular or intermittent inhaled steroids 6. 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). 7. Medication use: 1. Maternal use of tamoxifen during pregnancy or breastfeeding 2. Use of immunomodulatory medications such as methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant. 8. Use of another investigational agent in the last 30 days prior 9. Current parent reported diagnosis of mental illness or current self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements 10. Known allergy to soy protein (either by reported allergy or prior positive allergy results and no history of ongoing ingestion) or reported allergy to NovaSoyTM, from which the investigational product is compounded. 11. The infant is currently participating in another allergic disease (asthma, food allergy, or AD) -related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to enrollment 12. 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 study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 13. Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent prior to visit 1 (V1). 14. Non-adherence: 1. Inability / unwillingness of the parents to facilitate ingestion of the investigational product 2. Unwillingness of the parents to allow the staff to perform baseline procedures of nasal swabs 15. Participant is in foster care or is a ward of the state. 16. Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires) 17. Plan(s) for the family to move from the area during the study period 18. The infant's caretaker does not primarily speak English or Spanish.
Study sites (1)
IL
- Ann & Robert H Lurie Children's hospital of Chicago · Chicago, IL 60311Caroline Merck, MS · Study contact · 312-227-2469 · cmerck@luriechildrens.orgAliviya Schulze, BS · Study contact · 312-227-5391 · aschulze@luriechildrens.orgMore trials in Chicago