Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
Allogeneic Stem Cell Transplantation
About this trial
This is an interventional prevention trial for Allogeneic Stem Cell Transplantation focused on measuring bloodstream infections, oral health, xylitol, dental health, gingivitis, mucositis, plaque
Eligibility Criteria
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)
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Xylitol
Grape-flavored Wipes
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.
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.