NCT05579639 Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
| NCT ID | NCT05579639 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Allogeneic Stem Cell Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 419 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 419 participants in total. It began in 2023-04-04 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Christopher Dandoy, MD, MSc
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT05579639 clinical trial?
This trial is open to participants of all sexes, aged 4 Months or older, up to 25 Years, studying Allogeneic Stem Cell Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05579639 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05579639 currently recruiting?
Yes, NCT05579639 is actively recruiting participants. Contact the research team at Kelly.McIntosh@cchmc.org for enrollment information.
Where is the NCT05579639 trial being conducted?
This trial is being conducted at Aurora, United States, Boston, United States, Cincinnati, United States.
Who is sponsoring the NCT05579639 clinical trial?
NCT05579639 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Christopher Dandoy, MD, MSc at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 419 participants.