Phase 2 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The parent or guardian must be an adult (18 or older) who can understand and agree to the study requirements in writing.
• The baby must have been born at full term (at or after 37 weeks of pregnancy) and be younger than 12 months old when joining the study.
• The baby must be considered at higher risk for asthma, meaning: at least one parent had asthma that started in childhood, OR at least one parent developed asthma later in life AND also has allergies, eczema, or food allergies, OR the baby has already been diagnosed with eczema by a doctor.
• The baby must have a specific genetic marker (called the PAI-1 risk allele) identified through genetic testing — either one or two copies of it.
• The family must mainly live in certain pre-selected neighborhoods chosen for this study, OR live within the broader metro area defined by official boundaries and have publicly funded health insurance.
• At the time of being officially enrolled into the study, the baby must be between 4 and 11 months old and still have the required genetic marker confirmed.

Who may not be able to join:

• The parent or guardian is unable or unwilling to give written consent or follow the study plan.
• Parents who will not feed the baby pureed food or any type of bottle feeding (such as expressed breast milk, formula, or a small amount of water), since the study product needs to be given this way.
• The baby is currently on a soy-based formula.
• A breastfeeding mother who is taking soy supplements or eating soy-enriched foods more than twice a week and is unwilling to reduce this while breastfeeding.
• The baby is already on regular treatment for repeated wheezing, such as daily inhaled steroids.
• The baby has a known thyroid condition present from birth, or there is a family history of certain hormone-sensitive genetic conditions (such as BRCA1 mutations) (confirm with trial site).
• The mother took a medication called tamoxifen during pregnancy or is taking it while breastfeeding.
• The mother (if breastfeeding) or the baby is currently taking certain immune-suppressing medications such as methotrexate, mycophenolate, or azathioprine.
• The baby or family has been involved in another research study using an experimental treatment within the last 30 days.
• The primary caregiver has a current diagnosed or self-reported mental illness, drug use, or alcohol problem that the study team believes could affect their ability to follow study requirements.
• The baby or a parent has a known allergy to soy protein or to the specific soy ingredient used in the study product.
• The baby is currently in, or was recently in (within the past month), another asthma-related medication or treatment study.
• The baby or family has other medical, physical, or test-related issues that, in the study team's opinion, could make participation risky or affect the study results.
• The baby needed to be placed on a breathing machine (intubated) before the screening visit.
• The baby has been hospitalised more than 3 times for wheezing or asthma symptoms before the screening visit.
• The baby has needed more than 3 separate courses of oral steroids (each lasting about 5 days, at least 2 weeks apart) before the screening visit.
• The baby has any long-term condition that requires regular use of steroids or immune-suppressing medications.
• Parents are unwilling or unable to give the baby the study medication or to allow the study team to take baseline measurements.
• The baby is living with a foster parent as a ward of the state.
• The caregiver does not have access to a phone.
• The family plans to move out of the study area during the study period.
• The baby's main caregiver does not primarily speak English or Spanish.
• Between the first screening visit and the point of being officially enrolled, the baby cannot have had a severe wheezing episode that required an ICU stay, or more than two serious wheezing episodes each requiring a 5-day course of oral steroids.

Important: Always verify eligibility with the trial site directly before applying.