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.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Periodontal disease at 28-30 weeks of pregnancy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, data collectors (i.e. dental officers, study staff members, clinical officers), and data analysts will be blinded (triple-blinded) to group allocation throughout the study.
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Xylitol gum (Dietary Supplement)
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.
干预措施: Sorbitol gum (Dietary Supplement)
结局指标
主要结局
Periodontal disease at 28-30 weeks of pregnancy
时间窗: 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.
次要结局
- Periodontal disease at 6 weeks postpartum(Enrolment and 6 weeks postpartum)
- Alterations in the maternal oral microbiome communities(Enrolment and at 28-30 weeks, delivery and 4-6 weeks after)
- Alterations in the maternal vaginal microbiome communities(Enrolment and at 28-30 weeks, delivery and 4-6 weeks after)
- Inflammatory mediator changes in the maternal gingival crevicular fluid compared to changes in the placenta.(Enrolment and at 28-30 weeks, and at delivery)
- Alterations within the infants' oral microbiome communities(4-6 weeks)
- Alterations within the infants' gut microbiome communities(4-6 weeks)
- To determine the impact of chewing xylitol-containing gum (6.4 grams/day) vs placebo gum in pregnancy on neurodevelopmental outcomes of offspring at 6 and 18 months(At 6- and 18- months of corrected age.)
- To determine whether the addition of the DAYC-2 and HINE to the MDAT at 6 months of age improves the predictive validity for any NDD (1 SD below normative score on any MDAT domain), identified on the MDAT, DAYC-2 and/or HINE at 18 months corrected age.(6- and 18-months of corrected age)
- (Exploratory) To assess the intra-class correlation between an intensively trained Community Health Workers (CHW) in administering the MDAT, DAYC-2, and HINE as compared to a gold-standard examiner (Malawi-based Pediatric Neurologist).(6- and 18-months corrected age.)
研究者
Benjamin Chimarioff Shayo
Assistant Professor
Baylor College of Medicine