NCT04117477

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

October 3, 2019

Last Update Submit

February 3, 2023

Conditions

Allogeneic Hematopoietic Cell Transplantation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Xylitol wipes

EXPERIMENTAL
Drug: Xylitol

Placebo wipes

PLACEBO COMPARATOR
Other: Placebo

Interventions

XylitolDRUG

Xylitol dental wipes

Xylitol wipes
PlaceboOTHER

Placebo dental wipes

Placebo wipes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of any age undergoing SCT.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Interventions

Xylitol

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1:1, randomized, double-blind, placebo-controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

September 27, 2019

Primary Completion

March 20, 2021

Study Completion

March 20, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

US(1)