Clinical trial NCT06329596: Microbiome Alterations With Xylitol (MAX) in Pregnancy
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysbiosis
Inflammation Gum
Keywords: microbial alterations
xylitol
Malawi
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: University of Washington
name: Baylor College of Medicine Children's Foundation Malawi
First posted: 2024-03-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Periodontal disease at 28-30 weeks of pregnancy
timeFrame: Enrolment and 28-30 weeks of pregnancy.
Secondary outcomes:
measure: Periodontal disease at 6 weeks postpartum
timeFrame: Enrolment and 6 weeks postpartum
measure: Alterations in the maternal oral microbiome communities delivery
timeFrame: Enrolment and at 28-30 weeks, delivery and 4-6 weeks after
measure: Alterations in the maternal vaginal microbiome communities
timeFrame: Enrolment and at 28-30 weeks, delivery and 4-6 weeks after
measure: Inflammatory mediator changes in the maternal gingival crevicular fluid at
timeFrame: Enrolment and at 28-30 weeks, and 4-6 weeks after
measure: Alterations within the infants' oral microbiome communities
timeFrame: 4-6 weeks
measure: Alterations within the infants' gut microbiome communities
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Area 25 Health Center
Study officials:
affiliation: Baylor College of Medicine
name: Benjamin Shayo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. Treating periodontal disease for preventing adverse birth outcomes in pregnant women. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD005297. doi: 10.1002/14651858.CD005297.pub3.
citation: Soderling E, Pienihakkinen K. Effects of xylitol and erythritol consumption on mutans streptococci and the oral microbiota: a systematic review. Acta Odontol Scand. 2020 Nov;78(8):599-608. doi: 10.1080/00016357.2020.1788721. Epub 2020 Jul 7.
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citation: Soderling E, Pienihakkinen K, Gursoy UK. Effects of sugar-free polyol chewing gums on gingival inflammation: a systematic review. Clin Oral Investig. 2022 Dec;26(12):6881-6891. doi: 10.1007/s00784-022-04729-x. Epub 2022 Oct 14.
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