Xylitol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2021-03-20

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Allogeneic Hematopoietic Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1, randomized, double-blind, placebo-controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xylitol wipes

Group Type EXPERIMENTAL

Intervention Type DRUG

Xylitol dental wipes

Placebo wipes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo dental wipes

Interventions

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Xylitol

Xylitol dental wipes

Intervention Type DRUG

Placebo

Placebo dental wipes

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No