This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 2

Xylitol

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05579639

Conditions

Allogeneic Stem Cell Transplantation

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

Xylitol

Placebo

Study Details

Brief summary:

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.

Conditions

Allogeneic Stem Cell Transplantation

Study ID

NCT05579639

Start date

Apr 4, 2023

Status verified date

Jun, 2026

Completion date

Sep 11, 2026

Anticipated

Primary completion date

Jul 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

256 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Xylitol

Xylitol, a naturally occurring sugar alcohol found in plums, strawberries, and various vegetables such as cauliflower, has been approved for use in food by the US FDA since 1963. Spiffies Xylitol Wipes will be used.

placebo comparator: Grape-flavored Wipes

Grape-flavored wipes will be used with 2 drops of PCCA colorless grape flavoring. The grape-flavored wipes each contain a solution of 0.9% Sodium Chloride, purified water, and Benzalkonium chloride. PCCA artificial colorless grape flavoring will be used. The PCCA grape flavoring contains propylene glycol, ethyl alcohol, and artificial flavoring.

Interventions

Xylitol

Xylitol wipes

Placebo

Placebo wipes

Primary outcome measure

  • Bacteremia from an oral organism [ Time Frame: 33 days ]

Central Contacts and Locations

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • bloodstream infections
  • oral health
  • xylitol
  • dental health
  • gingivitis
  • mucositis
  • plaque

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-02. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.