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

Phase 2

Recruiting

• Conditions: Allogeneic Stem Cell Transplantation
• Interventions: Other: Xylitol; Other: Placebo

• Registration Number: NCT05579639
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

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 Timeline

• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Study Start: 2023-04-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2026-03-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 419

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xylitol	Xylitol	Xylitol, a naturally occurring sugar alcohol found in plums, strawberries, and various vegetables such as cauliflower, has been approved for use in food by the US FDA since 1963. Spiffies Xylitol Wipes will be used.
Grape-flavored Wipes	Placebo	Grape-flavored wipes will be used with 2 drops of PCCA colorless grape flavoring. The grape-flavored wipes each contain a solution of 0.9% Sodium Chloride, purified water, and Benzalkonium chloride. PCCA artificial colorless grape flavoring will be used. The PCCA grape flavoring contains propylene glycol, ethyl alcohol, and artificial flavoring.

Primary Outcome Measures

Name	Time	Method
Bacteremia from an oral organism	33 days	Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo

Secondary Outcome Measures

Name	Time	Method
Bacteremia from other non-oral flora organisms	33 days	Incidence of BSI from non-oral flora organisms in patients receiving xylitol compared to placebo
Dental plaque	33 days	Debris Index Simplified (DI-S) score
Gingivitis	33 days	Mean Modified Gingival Index (MGI) score
Objective mucositis	33 days	Mean Oral Mucositis Assessment Scale (OMAS) score
Oral microbiome diversity	33 days	Shannon Diversity Index
Patient-reported mucositis	33 days	ChIMES total score

Trial Locations

Locations (3)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Dana-Farber/Boston Children's; 🇺🇸 Boston, Massachusetts, United States