Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

Healthcare Associated Infection Reduction in Stem Cell Transplant Patients: a Randomized, Double-blind, Placebo-controlled Study Evaluating Twice Daily Xylitol Administration

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.

Study Overview

• Status: Terminated
• Conditions: Allogeneic Hematopoietic Cell Transplantation
• Intervention / Treatment: Drug: Xylitol; Other: Placebo

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 .

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Xylitol wipes	Drug: Xylitol; Xylitol dental wipes
PLACEBO_COMPARATOR: Placebo wipes	Other: Placebo; Placebo dental wipes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of dental plaque	30 days
Incidence of gingival inflammation	30 days
Incidence of mucosal ulceration	30 days
Incidence of oral mucositis	30 days
Incidence of oral microbiome diversity	30 days
Incidence of oral pathogenic bacteria burden	30 days

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2019
• Primary Completion (ACTUAL): March 20, 2021
• Study Completion (ACTUAL): March 20, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (ACTUAL): October 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: 2019-0261

Drug and device information, study documents

• 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