Can soy supplements stop infant wheezing from becoming asthma?

NCT ID NCT07828405

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

4 to 24 months

Sex

Anyone

Healthy volunteers

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

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.

Respiratory Sounds

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Ann & Robert H Lurie Children's hospital of Chicago

    Chicago, Illinois, 60311, United States

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