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Could chewing gum during pregnancy protect Babies' brains?

NCT ID NCT06329596

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study in Malawi tests whether chewing xylitol gum three times a day during pregnancy can improve gum health and change the bacteria in the mouth and vagina. Researchers will also check if it reduces pregnancy complications and affects babies' brain development. 80 pregnant women are participating, with half chewing xylitol gum and half chewing a similar gum without xylitol.

What this could mean

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

Active substance
Xylitol gum
What this could lead to
If it works, this could point toward a simple, low-cost way to improve gum health and reduce pregnancy complications in regions with limited dental care.
What could go wrong
This is an early-phase study with only 80 participants, so results may not apply broadly. Chewing gum may not be enough to significantly change the microbiome or prevent complications.

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

Phase 1/2

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

Participants

About 80 people

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

Started

Jun 2024

Expected to finish

Aug 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

12 to 60 years

Sex

Female participants only

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: * Able to provide informed consent. For those under 18 years of age, consent will additionally be sought from the parent or guardian. * A singleton at \<20 weeks' gestation (based on ultrasound or best obstetric measurement) * Planning to deliver at Area 25 health center. * Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy. * Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks, at delivery/within 48 hours and 4-6 weeks after giving birth. * Willing to have at least two vaginal sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks, at delivery/within 48 hours and 4-6 weeks after giving birth. * Able to speak Chichewa or English. * Cognitively aware enough to be able to participate in the study. * Willing to consent to all required aspects of protocol including allowing collection of placenta specimens, infant oral swab and meconium/stool sampling at birth/within 48 hours and 4-6 weeks after. Exclusion Criteria: * Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy. * Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others). * Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy. * Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta).

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Conditions

The condition(s) this trial relates to.

Dysbiosis gingivitis

As listed by the trial registrant

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

Dysbiosis Inflammation gum Microbioata Neurodevelopmental changes (childhood, ageing) Placenta-mediated pregnancy complications

Contacts and locations

Locations

  • Area 25 Health Center

    Lilongwe, Malawi

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