Xylitol Gum to Prevent Premature Birth and Protect Baby Health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II/III, individually randomized, double-blind trial testing two doses of xylitol-containing gum against a flavor-matched placebo gum in pregnant individuals before 20 weeks gestation. Participants chew the assigned gum several times daily through delivery to see if it lowers maternal periodontal disease, preterm birth, and low birthweight, and whether it improves child neurodevelopment at 2 years adjusted age. The study uses two active xylitol doses (6.4 g/day and 2.1 g/day) and a placebo, with oral hygiene and biospecimen collection included. Conducted in Lilongwe, Malawi, it involves serial dental exams and neurodevelopment follow-up, enrolling about 10,069 participants across multiple sites. Outcomes include obstetric, periodontal, neonatal, and neurodevelopmental metrics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian
* Less than 20 weeks' gestation (by best obstetric estimate)
* At least 20 natural teeth
* Planning to deliver at one of the health facilities within the XaPPP trial
* Receiving antenatal obstetric care at one of the 8 health districts
* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy
* Willing to attend all study visits
* Willing to provide biospecimens (oral, vaginal, placental, breast milk)
* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \<20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth
* Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s)
* Speaks Chichewa or English

All patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.

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)
* Known allergy to xylitol

Where it's running

• Baylor College of Medicine Children's Foundation Malawi
  Lilongwe, Malawi Recruiting

Study contacts

• Principal investigator: Greg Valentine — University of Washington
• Study coordinator: Greg Valentine, MD MED FAAP
• Email: gcvalent@uw.edu
• Phone: 2066167378

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.