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Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

Primary Purpose

Allogeneic Hematopoietic Cell Transplantation

Status
Terminated
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 Hematopoietic Cell Transplantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of any age undergoing SCT.

Exclusion Criteria:

  • Prior proton or photon radiation treatment for cancer of the oral cavity, head or neck; cranial boost in patients receiving total body irradiation; known history of allergy to xylitol; inability to use a mouth rinse or dental wipes.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xylitol wipes

Placebo wipes

Arm Description

Outcomes

Primary Outcome Measures

Incidence of bacteremia in the first 30 days post-HSCT with oral organisms
Incidence of bacteremia in the first 30 days post-HSCT with any organism

Secondary Outcome Measures

Incidence of dental plaque
Incidence of gingival inflammation
Incidence of mucosal ulceration
Incidence of oral mucositis
Incidence of oral microbiome diversity
Incidence of oral pathogenic bacteria burden

Full Information

First Posted
October 3, 2019
Last Updated
February 3, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04117477
Brief Title
Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients
Official Title
Healthcare Associated Infection Reduction in Stem Cell Transplant Patients: a Randomized, Double-blind, Placebo-controlled Study Evaluating Twice Daily Xylitol Administration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
A new multisite study was opened in place of this study.
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The central hypothesis is that daily dental xylitol wipes, in addition to current oral care practice, are effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral ulcerations after SCT.
Detailed Description
Our long-term goal is to develop and disseminate clinically relevant, and easily adoptable strategies to prevent BSI and improve outcomes after SCT. The overall objective of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial translocation through oral injured mucosa .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogeneic Hematopoietic Cell Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1, randomized, double-blind, placebo-controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xylitol wipes
Arm Type
Experimental
Arm Title
Placebo wipes
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xylitol
Intervention Description
Xylitol dental wipes
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo dental wipes
Primary Outcome Measure Information:
Title
Incidence of bacteremia in the first 30 days post-HSCT with oral organisms
Time Frame
30 days
Title
Incidence of bacteremia in the first 30 days post-HSCT with any organism
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of dental plaque
Time Frame
30 days
Title
Incidence of gingival inflammation
Time Frame
30 days
Title
Incidence of mucosal ulceration
Time Frame
30 days
Title
Incidence of oral mucositis
Time Frame
30 days
Title
Incidence of oral microbiome diversity
Time Frame
30 days
Title
Incidence of oral pathogenic bacteria burden
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of any age undergoing SCT. Exclusion Criteria: Prior proton or photon radiation treatment for cancer of the oral cavity, head or neck; cranial boost in patients receiving total body irradiation; known history of allergy to xylitol; inability to use a mouth rinse or dental wipes.
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States

12. IPD Sharing Statement

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Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

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