Microbiome Alterations With Xylitol (MAX) in Pregnancy

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.

Conditions

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

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.

Sponsors & Collaborators

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• University of Washington

  collaborator OTHER

• Baylor College of Medicine Children's Foundation Malawi

  collaborator UNKNOWN

• Thrasher Medical Research Foundation

  collaborator UNKNOWN

• Cure Within Reach

  collaborator UNKNOWN

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Benjamin Shayo, MD · Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-13

Primary Completion

2027-08-20

Completion

2027-08-31

Countries

• Malawi

Study Locations