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

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05579639

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR) (NIH)

419

Enrollment

Location

Arms

51.9

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Stem Cell Transplantation	Other: Xylitol Other: Placebo	Phase 2

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 hematopoietic stem cell transplant.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

419 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized, multicenter, double-blind, placebo-controlledrandomized, multicenter, double-blind, placebo-controlled

Masking:

Triple (Participant, Care Provider, 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.

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xylitol 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 Xylitol wipes Other Names: Spiffies Xylitol Wipes
Placebo Comparator: Grape-flavored Wipes 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 Placebo wipes Other Names: Grape-Flavored Wipes

Arm

Intervention/Treatment

Experimental: Xylitol

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

Xylitol wipes

Other Names:

Spiffies Xylitol Wipes

Placebo Comparator: Grape-flavored Wipes

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

Placebo wipes

Other Names:

Grape-Flavored Wipes

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Months to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)