Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 28, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT05579639). This is a study registration, not published results. Lead sponsor: Children's Hospital Medical Center, Cincinnati. Recruitment status: TERMINATED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 256 participants (ACTUAL). Conditions: Allogeneic Stem Cell Transplantation. Interventions: OTHER: Xylitol; OTHER: Placebo. Primary outcome measures: Bacteremia from an oral organism , 33 days. Brief 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.