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NCT Number: NCT05579639

Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant

Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable population. The investigators will conduct a randomized, double-blind, placebo-controlled trial at three institutions to evaluate the effectiveness of twice daily intraoral xylitol-wipe application on reducing BSI in pediatric SCT patients.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Allogeneic Stem Cell Transplantation Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Gingival Diseases Gingivitis Infections Inflammation Mouth Diseases Mucositis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque, Amyloid Sepsis Stomatognathic Diseases Systemic Inflammatory Response Syndrome

Age range

4 month–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

Loading trial locations.

About this study

Patients will be randomized to receive either twice-daily intraoral grape-flavored xylitol-wipe (intervention arm) or grape-flavored saline wipe (control arm) application in addition to the current standard of care (SOC). The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ulcers in the mouth), or gingivitis in patients who undergo allogeneic stem cell transplant (SCT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide signed and dated informed consent and assent (when applicable) form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Admitted and planning to undergo an allogeneic stem cell transplant (SCT) at Cincinnati Children's Hospital Medical Center (CCHMC), Boston Children's Hospital, or Children's Hospital of Colorado (Denver).
  • Male or female, 4 months to 25 years of age at the time of SCT (Day 0)
  • Have a minimum of one tooth
  • Agree to avoid chewing gum and toothpaste that contains xylitol during the intervention period

Exclusion criteria

  • Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6 months per the study participant's medical record
  • Cranial boost in patients receiving total body irradiation
  • Known history of allergy to xylitol
  • Known history of allergy to grapes or grape flavoring
  • Undergoing a conditioning-free allogeneic stem cell transplant (patient does not receive any chemotherapy or radiation prior to stem cell infusion)

Treatment and study plan

xylitol

Other

Xylitol wipes

Other names: Spiffies Xylitol Wipes

Placebo

Other

Placebo wipes

Other names: Grape-Flavored Wipes

Primary outcomes

  1. Bacteremia from an oral organism

    Time frame: 33 days

    Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo

Secondary outcomes

  1. Bacteremia from other non-oral flora organisms

    Time frame: 33 days

    Incidence of BSI from non-oral flora organisms in patients receiving xylitol compared to placebo

  2. Dental plaque

    Time frame: 33 days

    Debris Index Simplified (DI-S) score

  3. Gingivitis

    Time frame: 33 days

    Mean Modified Gingival Index (MGI) score

  4. Objective mucositis

    Time frame: 33 days

    Mean Oral Mucositis Assessment Scale (OMAS) score

  5. Patient-reported mucositis

    Time frame: 33 days

    ChIMES total score

  6. Oral microbiome diversity

    Time frame: 33 days

    Shannon Diversity Index

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant: a Randomized, Multicenter, Double-blind , Placebo-controlled Study Evaluating Twice Daily Oral Xylitol

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 14, 2022
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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