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Microbiome Alterations With Xylitol (MAX) in Pregnancy

Study acronym: MAX
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 20, 2025 to Aug 20, 2027 Completion date: Mar 31, 2027 to Aug 31, 2027 · Collaborators: 3 to 5 · Publications: details revised at 12 of 12 entriesv6 Show 3 more changesShow less
    • Completion date: Mar 31, 2027 to Aug 31, 2027
    • Collaborators: 3 to 5
    • Publications: details revised at 12 of 12 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Phase: Not applicable to Phase 1/2 Enrollment target: 50 to 80 · Primary completion date: Mar 31, 2025 to Dec 20, 2025 · Trial status: Recruiting to Active, Not Recruiting · 5 morev5 Show 8 more changesShow less
    • Enrollment target: 50 to 80
    • Primary completion date: Mar 31, 2025 to Dec 20, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Mar 31, 2026 to Mar 31, 2027
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 61 words
    • Site details revised
    • Publications: details revised at 12 of 12 entries

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  4. Start date: May 1, 2024 to Jun 13, 2024v3
  5. Start date: Apr 1, 2024 to May 1, 2024 Eligibility criteria revised · Study description revisedv2 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06329596
Lead Sponsor Baylor College of Medicine
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
Conditions Dysbiosis, Inflammation Gum, Placenta-mediated Pregnancy Complications, Microbioata, Neurodevelopmental Changes (Childhood, Ageing)
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov