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.
Patients will be randomized to receive either twice-daily intraoral grape-flavored xylitol-wipe (intervention arm) or grape-flavored saline wipe (control arm) application in addition to the current standard of care (SOC). The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ulcers in the mouth), or gingivitis in patients who undergo allogeneic stem cell transplant (SCT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
419
Xylitol wipes
Placebo wipes
Children's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGDana-Farber/Boston Children's
Boston, Massachusetts, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGBacteremia from an oral organism
Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo
Time frame: 33 days
Bacteremia from other non-oral flora organisms
Incidence of BSI from non-oral flora organisms in patients receiving xylitol compared to placebo
Time frame: 33 days
Dental plaque
Debris Index Simplified (DI-S) score
Time frame: 33 days
Gingivitis
Mean Modified Gingival Index (MGI) score
Time frame: 33 days
Objective mucositis
Mean Oral Mucositis Assessment Scale (OMAS) score
Time frame: 33 days
Patient-reported mucositis
ChIMES total score
Time frame: 33 days
Oral microbiome diversity
Shannon Diversity Index
Time frame: 33 days
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