RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-04
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05579639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Months to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provide signed and dated informed consent and assent (when applicable) form
  2. * Willing to comply with all study procedures and be available for the duration of the study
  3. * 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).
  4. * Male or female, 4 months to 25 years of age at the time of SCT (Day 0)
  5. * Have a minimum of one tooth
  6. * Agree to avoid chewing gum and toothpaste that contains xylitol during the intervention period
  1. * Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6 months per the study participant's medical record
  2. * Cranial boost in patients receiving total body irradiation
  3. * Known history of allergy to xylitol
  4. * Known history of allergy to grapes or grape flavoring
  5. * Undergoing a conditioning-free allogeneic stem cell transplant (patient does not receive any chemotherapy or radiation prior to stem cell infusion)

Contacts and Locations

Study Contact

Kelly McIntosh
CONTACT
513-803-0460
Kelly.McIntosh@cchmc.org

Principal Investigator

Christopher Dandoy, MD, MSc
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Dana-Farber/Boston Children's
Boston, Massachusetts, 02115
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Christopher Dandoy, MD, MSc, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • bloodstream infections
  • oral health
  • xylitol
  • dental health
  • gingivitis
  • mucositis
  • plaque

Additional Relevant MeSH Terms

  • Allogeneic Stem Cell Transplantation