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

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Oct 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether using xylitol wipes in the mouth can help reduce bloodstream infections (BSIs) in children and young adults undergoing a specific type of treatment called allogeneic stem cell transplantation. These infections can happen when bacteria enter the bloodstream through the mouth, especially in patients whose mouths are injured due to their treatment. The trial will involve participants applying xylitol wipes twice a day and will compare the results with those of a placebo (a treatment that looks the same but doesn’t contain the active ingredient) to see if there’s a difference in infection rates.

To be eligible for this study, participants need to be between 4 months and 25 years old and plan to have a stem cell transplant at one of the participating hospitals. They must also have at least one tooth and agree to avoid products containing xylitol during the study. Participants can expect to follow specific procedures and will be monitored throughout the study to gather important information about their health and the effectiveness of the xylitol wipes. This trial is currently recruiting, and the findings could lead to better ways to protect vulnerable patients from serious infections during their treatment.

Gender

ALL

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)