Recruiting

Testing a soy supplement to prevent asthma in at-risk infants

Plain-English translation of NCT05667701 on ClinicalTrials.gov ↗ · Source last updated November 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study is testing soy isoflavones — a natural compound found in soy — to see if it can help prevent asthma and wheezing in babies who are at high risk for developing the disease. Researchers will give some infants the soy supplement and others a matching placebo (a dummy treatment with no active ingredient) for 7 months, then follow them for another year to see if the treatment works.

Asthma is a common and serious condition in children, especially in inner-city communities. Doctors want to find safe, natural ways to prevent asthma from developing in babies who have family risk factors or early signs of the disease, before it becomes a bigger problem.

Do you qualify?

You likely qualify if…

you are the parent or guardian of an infant less than 12 months old
your baby has a family history of asthma (in you or the other parent) or has signs of allergic disease like eczema or food allergies
your baby has a specific genetic marker (PAI-1 risk genotype) identified through a simple genetic test
you live in one of the study's selected neighborhoods or have public health insurance in the area
you are able to give your baby the medication twice daily mixed into food or formula

You likely don't qualify if…

your baby is currently taking a soy-based formula
you (if breastfeeding) eat soy products or soy supplements more than twice a week and are unwilling to reduce this
your baby is already taking regular asthma medications like inhaled steroids
your baby or family has a history of thyroid disease or estrogen-sensitive genetic conditions like BRCA1
your baby has a known allergy to soy protein

What participation looks like

You will bring your infant to the clinic for a genetic test at the first visit. If your baby qualifies, you'll be randomly assigned to give either the soy supplement or a placebo powder mixed into your baby's food or formula twice daily for 7 months. During this time, you'll have about 6 visits (some virtual, some in person), plus extra visits if your baby gets sick. The study team will collect nasal swabs, blood samples, and stool samples at certain visits, and use a wearable device to measure your baby's breathing at night. After treatment ends, you'll continue follow-up visits for another year to see how your baby is doing.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Testing a soy supplement to prevent asthma in at-risk infants

What is this trial?

Do you qualify?

What participation looks like

Trial locations