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Could a simple gum reshape baby brain health? a new study investigates

NCT ID NCT05361122

Knowledge-focused Sponsor: University of Washington Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study follows 1,000 children in Malawi, aged 4 to 8, whose mothers either chewed xylitol gum during pregnancy or did not. Researchers will compare brain development, thinking skills, and emotional behavior between the two groups. They will also test a low-cost assessment tool against a gold-standard test to see if it can reliably measure development in this setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xylitol chewing gum (given to mothers during pregnancy in the parent trial)
What this could lead to
If children exposed to xylitol in the womb show normal or better development, it could support a simple, low-cost way to improve pregnancy outcomes and child health.
What could go wrong
This is a follow-up study, not a new treatment test. Results depend on past exposure and may not prove cause and effect. The assessment tools are being validated, so findings may be uncertain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

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

Started

Apr 2023

Expected to finish

Sep 2027

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 8 years

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: * Child born during the PPaX trial * Enrollment age between 4-8 years old * Parental or legal guardian consent obtained * Willing to undergo 3 neurodevelopmental tests * Willing to travel to BCMF for neurodevelopmental assessment * Assent by the pediatric subject for participation in the study Exclusion Criteria: * Parent or legal guardian cognitively unable to provide consent * Child unwilling to provide assent to participate in the study

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Conditions

The condition(s) this trial relates to.

neurodevelopmental disorder Premature Birth

As listed by the trial registrant

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

Neurodevelopmental disorders Prematurity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Baylor College of Medicine Children's Foundation-Malawi

    RECRUITING

    Lilongwe, Malawi

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