Actively Recruiting
Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-04-22
419
Participants Needed
3
Research Sites
221 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 at Cincinnati Children's Hospital Medical Center, Boston Children's Hospital, or Children's Hospital of Colorado
- Male or female, 4 months to 25 years of age at the time of stem cell transplant
- Have at least one tooth
- Agree to avoid chewing gum and toothpaste that contain xylitol during the study period
You will not qualify if you...
- Received radiation treatment for cancer of the oral cavity, head, or neck within the past 6 months
- Received a cranial boost in patients undergoing total body irradiation
- Known allergy to xylitol
- Known allergy to grapes or grape flavoring
- Undergoing a conditioning-free allogeneic stem cell transplant (no chemotherapy or radiation before stem cell infusion)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Dana-Farber/Boston Children's
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
K
Kelly McIntosh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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