Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

Phase 2

Terminated

• Conditions: Allogeneic Hematopoietic Cell Transplantation
• Interventions: Other: Placebo; Drug: Xylitol

• Registration Number: NCT04117477
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 .

Study Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Primary Completion: 2021-03-20
• Study Completion: 2021-03-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo wipes	Placebo	-
Xylitol wipes	Xylitol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of dental plaque	30 days
Incidence of oral microbiome diversity	30 days
Incidence of gingival inflammation	30 days
Incidence of oral pathogenic bacteria burden	30 days
Incidence of mucosal ulceration	30 days
Incidence of oral mucositis	30 days

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States