Microbiome Alterations With Xylitol (MAX) in Pregnancy

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.

NCT Number	NCT06329596
Lead Sponsor	Baylor College of Medicine Collaborators: Fogarty International Center of the National Institute of Health, University of Washington, Baylor College of Medicine Children's Foundation, Thrasher Medical Research Foundation, Cure Within Reach
Conditions	Dysbiosis, Inflammation Gum, Placenta-mediated Pregnancy Complications, Microbioata, Neurodevelopmental Changes (Childhood, Ageing)
Enrollment	80 participants
Start Date	2024-06-13
Primary Completion	2027-08-20 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-10