Microbiome Alterations With Xylitol (MAX) in Pregnancy

Baylor College of Medicine

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Dysbiosis

Microbioata

Placenta-mediated Pregnancy Complications

Neurodevelopmental Changes (Childhood, Ageing)

Inflammation Gum

Treatments

Dietary Supplement: Xylitol gum

Dietary Supplement: Sorbitol gum

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06329596

D43TW012274 (U.S. NIH Grant/Contract)

H-55146

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

Xylitol gum

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Xylitol gum

Sorbitol gum

Placebo Comparator group

Description:

Participants will receive Epic sorbitol-containing gum (0 grams xylitol/day); to chew two pieces for 5 minutes after meals, thrice a day.

Treatment:

Dietary Supplement: Sorbitol gum