Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329596
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-18
Brief Title:
Microbiome Alterations With Xylitol MAX in Pregnancy
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAX
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 636grams of daily xylitol Epic dental gum 106 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 gramsday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW012274 | NIH | None | httpsreporternihgovquickSearchD43TW012274 |