DysbiosisPhase 1/2MAXNCT06329596
Microbiome Alterations With Xylitol (MAX) in Pregnancy
A Phase 1/2 study testing Xylitol gum and Sorbitol gum in people with Dysbiosis and Inflammation Gum, run by Baylor College of Medicine at 1 site in Malawi.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 60 years, women only
- Conditions the study is for
- Dysbiosis, Inflammation Gum, Placenta-mediated Pregnancy Complications
- What is being tested?
- Xylitol gum and Sorbitol gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMalawi
- Study dates
- 13 Jun 2024to 31 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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 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.
- Conditions
- Dysbiosis, Inflammation Gum, Placenta-mediated Pregnancy Complications, Microbioata, Neurodevelopmental Changes (Childhood, Ageing)
- Being tested
- Xylitol gum, Sorbitol gum
- Keywords
- microbial alterations, xylitol, Malawi, infant neurodevelopment
- Medical subject headings
- Dysbiosis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol gumDietary supplement
Also called Epic Xylitol gum
Two pieces of xylitol gum after meals, thrice a day.
Sorbitol gumDietary supplement
Two pieces of sorbitol gum after meals, thrice a day.
| Study group | Role | What they receive |
|---|---|---|
| Xylitol gum | Experimental | 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. Receives: Dietary Supplement: Xylitol gum |
| Sorbitol gum | Placebo comparator | Participants will receive Epic sorbitol-containing gum (0 grams xylitol/day); to chew two pieces for 5 minutes after meals, thrice a day. Receives: Dietary Supplement: Sorbitol gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal disease at 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.
Measured: Enrolment and 28-30 weeks of pregnancy.
Secondary outcomes (9)
Periodontal disease at 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.
Measured: Enrolment and 6 weeks postpartum
Alterations in the maternal oral microbiome communities
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.
Measured: Enrolment and at 28-30 weeks, delivery and 4-6 weeks after
Alterations in the maternal vaginal microbiome communities
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
Measured: 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.
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.
Measured: Enrolment and at 28-30 weeks, and at delivery
Alterations within the infants' oral microbiome communities
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.
Measured: 4-6 weeks
Alterations within the infants' gut microbiome communities
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.
Measured: 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
We will use the MDAT z-score as a primary outcome. Secondary outcomes include DAYC-2 raw score and HINE optimality scores and asymmetries. Relevant descriptive statistics, and non-parametric tests will be used in analysis.
Measured: 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.
We will utilise logistic regression to establish a predictive model for addition of the DAYC-2 and HINE to MDAT for NDD at 18 months corrected age.
Measured: 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).
We will use standard measures including Cronbach's alpha coefficient to compare all assessments between CHW and the gold standard examiner and generate a Bland-Altman plot. We will use the results of this exploratory aim to inform a power calculation for a planned future large investigation to determine how many assessments are needed by two examiners to assess the reliability of CHW exams.
Measured: 6- and 18-months corrected age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start13 Jun 2024
- Primary completion20 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of Washington, Baylor College of Medicine Children's Foundation, Thrasher Medical Research Foundation, Cure Within Reach
- Responsible party
- Principal investigator, Benjamin Chimarioff Shayo, Baylor College of Medicine
- Investigators
- Benjamin Shayo, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329596
- Sponsor's protocol ID
- H-55146
- Other IDs
- D43TW012274
- Acronym
- MAX
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Chen P, Hong F, Yu X. Prevalence of periodontal disease in pregnancy: A systematic review and meta-analysis. J Dent. 2022 Oct;125:104253. doi: 10.1016/j.jdent.2022.104253. Epub 2022 Aug 20.
PubMed 35998741Robinson JL, Johnson PM, Kister K, Yin MT, Chen J, Wadhwa S. Estrogen signaling impacts temporomandibular joint and periodontal disease pathology. Odontology. 2020 Apr;108(2):153-165. doi: 10.1007/s10266-019-00439-1. Epub 2019 Jul 3.
PubMed 31270648Alnasser BH, Alkhaldi NK, Alghamdi WK, Alghamdi FT. The Potential Association Between Periodontal Diseases and Adverse Pregnancy Outcomes in Pregnant Women: A Systematic Review of Randomized Clinical Trials. Cureus. 2023 Jan 1;15(1):e33216. doi: 10.7759/cureus.33216. eCollection 2023 Jan.
PubMed 36733569Bobetsis YA, Graziani F, Gursoy M, Madianos PN. Periodontal disease and adverse pregnancy outcomes. Periodontol 2000. 2020 Jun;83(1):154-174. doi: 10.1111/prd.12294.
PubMed 32385871Zhang Y, Feng W, Li J, Cui L, Chen ZJ. Periodontal Disease and Adverse Neonatal Outcomes: A Systematic Review and Meta-Analysis. Front Pediatr. 2022 May 4;10:799740. doi: 10.3389/fped.2022.799740. eCollection 2022.
PubMed 35601423Iheozor-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.
PubMed 28605006Soderling 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.
PubMed 32633595Marghalani AA, Guinto E, Phan M, Dhar V, Tinanoff N. Effectiveness of Xylitol in Reducing Dental Caries in Children. Pediatr Dent. 2017 Mar 15;39(2):103-110.
PubMed 28390459Gudnadottir U, Debelius JW, Du J, Hugerth LW, Danielsson H, Schuppe-Koistinen I, Fransson E, Brusselaers N. The vaginal microbiome and the risk of preterm birth: a systematic review and network meta-analysis. Sci Rep. 2022 May 13;12(1):7926. doi: 10.1038/s41598-022-12007-9.
PubMed 35562576Loimaranta V, Mazurel D, Deng D, Soderling E. Xylitol and erythritol inhibit real-time biofilm formation of Streptococcus mutans. BMC Microbiol. 2020 Jun 29;20(1):184. doi: 10.1186/s12866-020-01867-8.
PubMed 32600259Soderling 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.
PubMed 36239787Soderling E, Pienihakkinen K. Effects of xylitol chewing gum and candies on the accumulation of dental plaque: a systematic review. Clin Oral Investig. 2022 Jan;26(1):119-129. doi: 10.1007/s00784-021-04225-8. Epub 2021 Oct 22.
PubMed 34677696
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06329596
- Acronym / sponsor ID
- MAX / H-55146
- Conditions
- Dysbiosis, Inflammation Gum, Placenta-mediated Pregnancy Complications, Microbioata, Neurodevelopmental Changes (Childhood, Ageing)
- Keywords
- microbial alterations, xylitol, Malawi, infant neurodevelopment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of Washington, Baylor College of Medicine Children's Foundation, Thrasher Medical Research Foundation, Cure Within Reach
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylitol gum | Experimental | Dietary Supplement: Xylitol gumParticipants 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. |
| Sorbitol gum | Placebo comparator | Dietary Supplement: Sorbitol gumParticipants will receive Epic sorbitol-containing gum (0 grams xylitol/day); to chew two pieces for 5 minutes after meals, thrice a day. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xylitol gumAlso: Epic Xylitol gumTwo pieces of xylitol gum after meals, thrice a day. | Dietary supplement | Xylitol gum |
| Sorbitol gumTwo pieces of sorbitol gum after meals, thrice a day. | Dietary supplement | Sorbitol gum |
Primary outcome
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.
9 secondary outcomes
Periodontal disease at 6 weeks postpartum
Time frame: Enrolment and 6 weeks postpartum
Alterations in the maternal oral microbiome communities
Time frame: 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
Inflammatory mediator changes in the maternal gingival crevicular fluid compared to changes in the placenta.
Time frame: Enrolment and at 28-30 weeks, and at delivery
Alterations within the infants' oral microbiome communities
Time frame: 4-6 weeks
Alterations within the infants' gut microbiome communities
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 6- and 18-months corrected age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 35998741Chen P, Hong F, Yu X. Prevalence of periodontal disease in pregnancy: A systematic review and meta-analysis. J Dent. 2022 Oct;125:104253. doi: 10.1016/j.jdent.2022.104253. Epub 2022 Aug 20.
- Results publication: PubMed 31270648Robinson JL, Johnson PM, Kister K, Yin MT, Chen J, Wadhwa S. Estrogen signaling impacts temporomandibular joint and periodontal disease pathology. Odontology. 2020 Apr;108(2):153-165. doi: 10.1007/s10266-019-00439-1. Epub 2019 Jul 3.
- Results publication: PubMed 36733569Alnasser BH, Alkhaldi NK, Alghamdi WK, Alghamdi FT. The Potential Association Between Periodontal Diseases and Adverse Pregnancy Outcomes in Pregnant Women: A Systematic Review of Randomized Clinical Trials. Cureus. 2023 Jan 1;15(1):e33216. doi: 10.7759/cureus.33216. eCollection 2023 Jan.
- Results publication: PubMed 32385871Bobetsis YA, Graziani F, Gursoy M, Madianos PN. Periodontal disease and adverse pregnancy outcomes. Periodontol 2000. 2020 Jun;83(1):154-174. doi: 10.1111/prd.12294.
- Results publication: PubMed 35601423Zhang Y, Feng W, Li J, Cui L, Chen ZJ. Periodontal Disease and Adverse Neonatal Outcomes: A Systematic Review and Meta-Analysis. Front Pediatr. 2022 May 4;10:799740. doi: 10.3389/fped.2022.799740. eCollection 2022.
- Results publication: PubMed 28605006Iheozor-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.
- Results publication: PubMed 32633595Soderling 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.
- Results publication: PubMed 28390459Marghalani AA, Guinto E, Phan M, Dhar V, Tinanoff N. Effectiveness of Xylitol in Reducing Dental Caries in Children. Pediatr Dent. 2017 Mar 15;39(2):103-110.
- Results publication: PubMed 35562576Gudnadottir U, Debelius JW, Du J, Hugerth LW, Danielsson H, Schuppe-Koistinen I, Fransson E, Brusselaers N. The vaginal microbiome and the risk of preterm birth: a systematic review and network meta-analysis. Sci Rep. 2022 May 13;12(1):7926. doi: 10.1038/s41598-022-12007-9.
- Results publication: PubMed 32600259Loimaranta V, Mazurel D, Deng D, Soderling E. Xylitol and erythritol inhibit real-time biofilm formation of Streptococcus mutans. BMC Microbiol. 2020 Jun 29;20(1):184. doi: 10.1186/s12866-020-01867-8.
- Results publication: PubMed 36239787Soderling 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.
- Results publication: PubMed 34677696Soderling E, Pienihakkinen K. Effects of xylitol chewing gum and candies on the accumulation of dental plaque: a systematic review. Clin Oral Investig. 2022 Jan;26(1):119-129. doi: 10.1007/s00784-021-04225-8. Epub 2021 Oct 22.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Shayo, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xylitol gum and Sorbitol gum in people with Dysbiosis and Inflammation Gum, run by Baylor College of Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal disease at 28-30 weeks of pregnancy (time frame: Enrolment and 28-30 weeks of pregnancy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06329596, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.