Clinical trial NCT05579639: Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Allogeneic Stem Cell Transplantation
Keywords: bloodstream infections
oral health
xylitol
dental health
gingivitis
mucositis
plaque
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2022-10-14
Enrollment: 419
Sex: ALL
Minimum age (years): 4
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, multicenter, double-blind, placebo-controlled
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Bacteremia from an oral organism
timeFrame: 33 days
Secondary outcomes:
measure: Bacteremia from other non-oral flora organisms
timeFrame: 33 days
measure: Dental plaque
timeFrame: 33 days
measure: Gingivitis
timeFrame: 33 days
measure: Objective mucositis
timeFrame: 33 days
measure: Patient-reported mucositis
timeFrame: 33 days
measure: Oral microbiome diversity
timeFrame: 33 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Boston
country: United States
facility: Dana-Farber/Boston Children's
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Christopher Dandoy, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: