Can soy supplements stop infant wheezing from becoming asthma?
NCT ID NCT07828405
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are studying whether a common nutritional supplement, soy isoflavones, can reduce airway changes in infants who have a specific gene variation and are sick with a viral respiratory infection. The trial enrolls 60 infants aged 4 to 24 months who come to the hospital with a lower respiratory tract infection. Half will receive soy isoflavones by mouth for up to 7 days, and the study will measure markers of airway inflammation and remodeling to see if the supplement makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Soy isoflavone nutritional supplements
- What this could lead to
- If it works, this could point toward a simple nutritional approach to protect infants at higher genetic risk from developing asthma after a severe viral illness.
- What could go wrong
- This is an early-phase trial in only 60 infants, so it may not show a clear benefit. Soy isoflavones could cause mild digestive upset, and the results may not apply to all children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 24 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ann & Robert H Lurie Children's hospital of Chicago
Chicago, Illinois, 60311, United States
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Other studies related to the condition(s) this trial covers.
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- Could a common antibiotic ease severe wheezing in young children?
- App aims to shield kids from smoke at home