Allogeneic Stem Cell Transplantation
Conditions
Keywords
bloodstream infections, oral health, xylitol, dental health, gingivitis, mucositis, plaque
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).
Interventions
OTHERXylitol
Xylitol wipes
OTHERPlacebo
Placebo wipes
Sponsors
Children's Hospital Medical Center, Cincinnati
National Institute of Dental and Craniofacial Research (NIDCR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants, parents/guardians, nursing staff (interventionists), oral evaluators, and investigators will be blinded to the intervention, administered in the form of twice-daily grape-flavored xylitol wipes or grape-flavored saline wipes (controls). Preformed packets will be prepared by CCHMC Investigational Pharmacy staff, which will consist of either saline wipes with natural grape flavoring or xylitol. The color, taste, and smell of the wipes will be identical. The statistician will be unblinded to treatment assignment for the analysis.
Intervention model description
randomized, multicenter, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
4 Months to 25 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patient-reported mucositis | 33 days | ChIMES total score |
| Oral microbiome diversity | 33 days | Shannon Diversity Index |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Dandoy, MD, MSc
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed