Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

Allogeneic Hematopoietic Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04117477
• Other study ID #: 2019-0261
• Status: Terminated
• Phase: Phase 2
• Start date: September 27, 2019
• Est. completion date: March 20, 2021

Study information

• Verified date: February 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Cell Transplantation
• Cross Infection

Intervention

Drug:
• Xylitol
Xylitol dental wipes

Other:
• Placebo
Placebo dental wipes

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bacteremia in the first 30 days post-HSCT with oral organisms		30 days
Primary	Incidence of bacteremia in the first 30 days post-HSCT with any organism		30 days
Secondary	Incidence of dental plaque		30 days
Secondary	Incidence of gingival inflammation		30 days
Secondary	Incidence of mucosal ulceration		30 days
Secondary	Incidence of oral mucositis		30 days
Secondary	Incidence of oral microbiome diversity		30 days
Secondary	Incidence of oral pathogenic bacteria burden		30 days