Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Allogeneic Stem Cell Transplantation
In brief
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.
Key facts
- Study ID
- NCT05579639
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 256
- Starts
- 2023-04-04
- Expected to finish
- 2026-09-11
- Last updated by the study team
- 2026-06-22
Who can join
Age: 0 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- 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
Full record on ClinicalTrials.gov
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