NCT06329596

Microbiome Alterations With Xylitol (MAX) in Pregnancy

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.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Female
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease) and placentae, and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi. In addition, we will evaluate the impact of xylitol-containing chewing gum use during pregnancy on the offsprings neurodevelopment at approximately 6- and 18-months corrected age.

Detailed description

After consenting to the study, pregnant participants who have a singleton gestation and are \<20 weeks' gestation will be randomised into either the intervention arm ( 6.36grams of daily xylitol; Epic dental gum, 1.06 grams Xylitol per piece of gum; chew two pieces for 5 minutes after meals, thrice a day) or the placebo control arm (Sorbitol Gum base; Epic sorbitol-containing gum, 0 grams/day of xylitol; chew two pieces for 5 minutes after meals, thrice a day) by randomly picking from a group of opaque, sealed envelopes containing group allocation. The participants will also undergo a dental assessment and sampling, and vaginal sampling at enrolment, 28- 30 weeks of pregnancy, at birth - 48 hours and 4-6 weeks after birth. In addition, placental and breastmilk specimens will be obtained at the time of delivery, and stored in a biobank for future analyses. The investigators will also obtain oral and meconium (and stool at 4-6 weeks) samples of their newborns at birth and 4-6 weeks after birth. Furthermore, at 6- and 18-months corrected age, the infants will undergo neurodevelopmental assessments using the the Hammersmith Infant Neurologic Exam (HINE), Developmental Assessment of Young Children 2nd Edition (DAY-C), and Malawi Development Assessment Tool (MDAT). The assessments will be done by two community health workers trained in these methods and will be compared to assessments by a paediatric neurologist.

Conditions

• Dysbiosis
• Inflammation Gum
• Placenta-mediated Pregnancy Complications
• Microbioata
• Neurodevelopmental Changes (Childhood, Ageing)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Xylitol gum	Two pieces of xylitol gum after meals, thrice a day.
DIETARY_SUPPLEMENT	Sorbitol gum	Two pieces of sorbitol gum after meals, thrice a day.

Timeline

• Start date: 2024-06-13
• Primary completion: 2027-08-20
• Completion: 2027-08-31
• First posted: 2024-03-26
• Last updated: 2026-03-10

Locations

1 site across 1 country: Malawi