Reducing bloodstream infections in pediatric stem cell transplant patients using xylitol wipes
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
PHASE2 · Children's Hospital Medical Center, Cincinnati · NCT05579639
This study is testing if using xylitol wipes in the mouths of kids getting stem cell transplants can help prevent bloodstream infections and improve their oral health.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 419 (estimated) |
| Ages | 4 Months to 25 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Trial ID | NCT05579639 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of twice-daily intraoral xylitol wipes in reducing bloodstream infections (BSIs) caused by oral bacteria in pediatric patients undergoing allogeneic stem cell transplantation. Participants will be randomly assigned to receive either xylitol wipes or a placebo saline wipe, in addition to standard care. The study aims to assess not only the reduction of BSIs but also improvements in dental plaque, mucositis, and gingivitis. Conducted at three major children's hospitals, this double-blind, placebo-controlled trial seeks to provide a novel preventive strategy for a vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 4 months to 25 years who are admitted for an allogeneic stem cell transplant and have at least one tooth.
Not a fit: Patients with a known allergy to xylitol or grape flavoring, or those who have received prior radiation treatment for oral cancers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of bloodstream infections in pediatric stem cell transplant patients, improving their overall health outcomes.
How similar studies have performed: While this approach is novel in the context of pediatric stem cell transplantation, similar studies have shown promise in using xylitol for oral health improvements.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aurora, Colorado and 2 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
- Dana-Farber/Boston Children's — Boston, Massachusetts, United States (RECRUITING)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Christopher Dandoy, MD, MSc — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Kelly McIntosh
- Email: Kelly.McIntosh@cchmc.org
- Phone: 513-803-0460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allogeneic Stem Cell Transplantation, bloodstream infections, oral health, xylitol, dental health, gingivitis, mucositis, plaque