Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06329596
PHASE1/PHASE2

Microbiome Alterations With Xylitol (MAX) in Pregnancy

Sponsor: Baylor College of Medicine

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

FEMALE

Age Range

12 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-06-13

Completion Date

2027-08-31

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

Area 25 Health Center

Lilongwe, Malawi