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

Primary Purpose

Allogeneic Stem Cell Transplantation

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Xylitol
Placebo
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allogeneic Stem Cell Transplantation focused on measuring bloodstream infections, oral health, xylitol, dental health, gingivitis, mucositis, plaque

Eligibility Criteria

4 Months - 25 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xylitol

Grape-flavored Wipes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
October 11, 2022
Last Updated
April 12, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT05579639
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogeneic Stem Cell Transplantation
Keywords
bloodstream infections, oral health, xylitol, dental health, gingivitis, mucositis, plaque

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, multicenter, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
419 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xylitol
Arm Type
Experimental
Arm Description
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.
Arm Title
Grape-flavored Wipes
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Xylitol
Other Intervention Name(s)
Spiffies Xylitol Wipes
Intervention Description
Xylitol wipes
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Grape-Flavored Wipes
Intervention Description
Placebo wipes
Primary Outcome Measure Information:
Title
Bacteremia from an oral organism
Description
Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo
Time Frame
33 days
Secondary Outcome Measure Information:
Title
Bacteremia from other non-oral flora organisms
Description
Incidence of BSI from non-oral flora organisms in patients receiving xylitol compared to placebo
Time Frame
33 days
Title
Dental plaque
Description
Debris Index Simplified (DI-S) score
Time Frame
33 days
Title
Gingivitis
Description
Mean Modified Gingival Index (MGI) score
Time Frame
33 days
Title
Objective mucositis
Description
Mean Oral Mucositis Assessment Scale (OMAS) score
Time Frame
33 days
Title
Patient-reported mucositis
Description
ChIMES total score
Time Frame
33 days
Title
Oral microbiome diversity
Description
Shannon Diversity Index
Time Frame
33 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly McIntosh
Phone
513-803-0460
Email
Kelly.McIntosh@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Dandoy, MD, MSc
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly McIntosh
Phone
513-803-0460
Email
Kelly.McIntosh@cchmc.org
First Name & Middle Initial & Last Name & Degree
Christopher Dandoy, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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