Microbiome Alterations With Xylitol (MAX) in Pregnancy (MAX)

April 18, 2024 updated by: Benjamin Chimarioff Shayo, Baylor College of Medicine

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.

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 the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xylitol gum
Participants will receive 6.36grams of daily xylitol; Epic dental gum, 1.06 grams Xylitol per piece of gum; to chew two pieces for 5 minutes after meals, thrice a day.
Dietary supplement: Xylitol gum
Two pieces of xylitol gum after meals, thrice a day.
Other Names:
  • Epic Xylitol gum
Placebo Comparator: Sorbitol gum
Participants will receive Epic sorbitol-containing gum (0 grams xylitol/day); to chew two pieces for 5 minutes after meals, thrice a day.
Dietary supplement: Sorbitol gum
Two pieces of sorbitol gum after meals, thrice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal disease at 28-30 weeks of pregnancy
Time Frame: Enrolment and 28-30 weeks of pregnancy.
The investigators will create scaled periodontal disease score comprising of sum of scores for gingival bleeding (+1 if bleeding was present, per tooth), gingival pockets (+1 for pockets of 4-5 mm and +2 for 6 mm or deeper, per tooth), and loss of attachment (+1 for 4-5 mm loss, +2 for 6-8 mm, +3 for 9-11 mm, and +4 for 12 mm or more, per tooth with values recorded for index teeth) divided by the number of teeth present will be created for every dental visit. A score of >0 will indicate presence of periodontal disease. The investigators will compare periodontal disease status at 28-30 weeks of pregnancy to that at enrolment.
Enrolment and 28-30 weeks of pregnancy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal disease at 6 weeks postpartum
Time Frame: Enrolment and 6 weeks postpartum
The investigators will create scaled periodontal disease score comprising of sum of scores for gingival bleeding (+1 if bleeding was present, per tooth), gingival pockets (+1 for pockets of 4-5 mm and +2 for 6 mm or deeper, per tooth), and loss of attachment (+1 for 4-5 mm loss, +2 for 6-8 mm, +3 for 9-11 mm, and +4 for 12 mm or more, per tooth with values recorded for index teeth) divided by the number of teeth present will be created for every dental visit. A score of >0 will indicate presence of periodontal disease. The investigators will compare periodontal disease status at 6 weeks postpartum to that at enrolment.
Enrolment and 6 weeks postpartum
Alterations in the maternal oral microbiome communities delivery
Time Frame: Enrolment and at 28-30 weeks, delivery and 4-6 weeks after
Using 16S rRNA sequencing to assess strain level changes in sub gingival plaque composition within and between those exposed to xylitol and placebo gum using exact amplicon sequence variants.
Enrolment and at 28-30 weeks, delivery and 4-6 weeks after
Alterations in the maternal vaginal microbiome communities
Time Frame: Enrolment and at 28-30 weeks, delivery and 4-6 weeks after
Using 16S rRNA sequencing to assess strain level changes in the vaginal microbiome at the vaginal introitus and posterior fornix. The investigators will compare compositional differences between sites in relationship to treatment
Enrolment and at 28-30 weeks, delivery and 4-6 weeks after
Inflammatory mediator changes in the maternal gingival crevicular fluid at
Time Frame: Enrolment and at 28-30 weeks, and 4-6 weeks after
The investigators will assess changes in local oral inflammation associated with xylitol exposure or not by evaluating the gingival crevicular fluid using a 10-plex pro inflammatory cytokine panel.
Enrolment and at 28-30 weeks, and 4-6 weeks after
Alterations within the infants' oral microbiome communities
Time Frame: 4-6 weeks
The investigators will us 16S rRNA sequencing to assess strain level changes within the oral swabs of the infants born during the MAX trial and assess changes in the composition within and between those exposed to xylitol and placebo gum.
4-6 weeks
Alterations within the infants' gut microbiome communities
Time Frame: 4-6 weeks
The investigators will use 16S rRNA sequencing to assess strain level changes in the stool/meconium samples from the infants' gut microbiome and assess compositional changes within and between those exposed to xylitol and placebo gum.
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

University of Washington
Fogarty International Center of the National Institute of Health
Baylor College of Medicine Children's Foundation Malawi

Investigators

  • Principal Investigator: Benjamin Shayo, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-55146
  • D43TW012274 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared for investigators who have an IRB approved project and approach the researchers with a research plan that is approved by the study team.

IPD Sharing Time Frame

1 year after the study conclusion will the data become available and be available for approximately 10 years after study completion.

IPD Sharing Access Criteria

Investigators interested in the study data should contact the Study PI (Dr. Ben Shayo - Benjamin.shayo@bcm.edu) or study team members (i.e. Dr. Greg Valentine - gcvalent@uw.edu).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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