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

What this Trial Is About

Bloodstream infections caused by bacteria crossing injured oral mucosa are a serious concern for children and young adults undergoing allogeneic stem cell transplantation (SCT). This trial evaluates whether using intraoral xylitol wipes twice daily can reduce these infections, dental plaque, mucositis, and gingivitis in pediatric SCT patients. The study is a randomized, double-blind, placebo-controlled trial conducted at multiple institutions to explore a potential preventive strategy for this vulnerable group. Participants will be randomly assigned to receive either grape-flavored xylitol wipes or grape-flavored saline wipes (placebo), applied inside the mouth twice daily alongside their standard care. The xylitol wipes contain a naturally occurring sugar alcohol approved for food use, while the placebo wipes contain saline and grape flavoring. Both treatments will be used for up to 33 days, covering the critical period around stem cell transplantation. During the study, participants will be closely monitored for bloodstream infections from oral bacteria and other organisms, dental plaque, gingivitis, and mucositis through objective assessments and patient reports. Researchers will also analyze changes in the oral microbiome over 33 days. Participants must comply with study procedures, avoid xylitol gum and toothpaste, and will be followed throughout the intervention period to assess safety and treatment impact.

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