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

Study Overview
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Brief Summary
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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
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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 hematopoietic stem cell transplant.

Official Title
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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

Conditions
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Allogeneic Stem Cell Transplantation

Intervention / Treatment
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* Other: Xylitol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, multicenter, double-blind, placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylitol<br>Xylitol, a naturally occurring sugar alcohol found in plums, strawberries, and various vegetables such as cauliflower, has been approved for use in food by the US FDA since 1963. Spiffies Xylitol Wipes will be used. | Other: Xylitol<br>* Xylitol wipes<br>* Other names: Spiffies Xylitol Wipes;|
| Placebo Comparator: Grape-flavored Wipes<br>Grape-flavored wipes will be used with 2 drops of PCCA colorless grape flavoring. The grape-flavored wipes each contain a solution of 0.9% Sodium Chloride, purified water, and Benzalkonium chloride. PCCA artificial colorless grape flavoring will be used. The PCCA grape flavoring contains propylene glycol, ethyl alcohol, and artificial flavoring. | Other: Placebo<br>* Placebo wipes<br>* Other names: Grape-Flavored Wipes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteremia from an oral organism | Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo | 33 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteremia from other non-oral flora organisms | Incidence of BSI from non-oral flora organisms in patients receiving xylitol compared to placebo | 33 days | 
| Dental plaque | Debris Index Simplified (DI-S) score | 33 days | 
| Gingivitis | Mean Modified Gingival Index (MGI) score | 33 days | 
| Objective mucositis | Mean Oral Mucositis Assessment Scale (OMAS) score | 33 days | 
| Patient-reported mucositis | ChIMES total score | 33 days | 
| Oral microbiome diversity | Shannon Diversity Index | 33 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plaque, bloodstream infections, oral health, xylitol, dental health, gingivitis, mucositis