Microbiome Alterations With Xylitol (MAX) in Pregnancy

Launched by BAYLOR COLLEGE OF MEDICINE · Mar 25, 2024

Keywords

ClinConnect Summary

The Microbiome Alterations With Xylitol (MAX) study is looking to find out if chewing xylitol gum during pregnancy can change the types of bacteria in the mouth and vagina, reduce inflammation in the gums, and affect the bacteria in newborns. Pregnant women in Malawi who are less than 20 weeks along and planning to deliver at a specific health center are invited to participate. To be eligible, they must be able to provide consent, chew gum three times a day after meals, and agree to several dental and vaginal exams throughout their pregnancy and after giving birth.

Participants in this study will need to chew two pieces of xylitol gum for five minutes after breakfast, lunch, and dinner every day until they give birth. They will also have to undergo dental exams and provide samples at different times during their pregnancy and shortly after delivering their baby. This study may help improve understanding of how oral health during pregnancy can impact both the mother and baby's health.

Gender

FEMALE

Eligibility 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).