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RecruitingPhase 2NCT05579639

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

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

419 participants

Start Date

Apr 4, 2023

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 4 MonthsMax Age: 25 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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)

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Interventions

OTHERXylitol

Xylitol wipes

OTHERPlacebo

Placebo wipes

Locations(3)

Children's Hospital Colorado

Aurora, Colorado, United States

Dana-Farber/Boston Children's

Boston, Massachusetts, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT05579639