Effects of Xylitol Gum on Oral and Vaginal Microbiome in Pregnant Women
Periodontal Disease and Alterations in the Oral and Vaginal Microbiome Communities Among Gravidae Chewing Xylitol-gum in Malawi: Microbiome Alterations With Xylitol (MAX) in Pregnancy Trial.
This study is testing whether chewing xylitol gum can improve the oral and vaginal health of pregnant women in Malawi and their newborns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 12 Years to 60 Years |
| Sex | Female |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT06329596 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of chewing xylitol gum on the oral and vaginal microbiome of pregnant women in Malawi. Participants who are less than 20 weeks pregnant will be randomly assigned to either chew xylitol gum or a placebo gum throughout their pregnancy. The study will assess changes in microbial populations, signs of inflammation in the gums, and the health of oral tissues, as well as collect samples from the participants and their newborns at various stages. The goal is to understand how xylitol may influence both maternal and neonatal health.
Who should consider this trial
Good fit: Ideal candidates are pregnant women in Malawi who are less than 20 weeks gestation and can provide informed consent.
Not a fit: Patients who are not pregnant or those with multiple gestations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oral and vaginal health outcomes for pregnant women and their newborns.
How similar studies have performed: While there is limited research specifically on xylitol's effects during pregnancy, similar studies on xylitol's impact on oral health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Lilongwe
- Area 25 Health Center — Lilongwe, Malawi (Recruiting)
Study contacts
- Principal investigator: Benjamin Shayo, MD — Baylor College of Medicine
- Study coordinator: Benjamin Shayo, MD
- Email: benjamin.shayo@bcm.edu
- Phone: +265980888996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.