Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04117477

Collaborator

(none)

356

Enrollment

Location

Arms

38.1

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Hematopoietic Cell Transplantation	Drug: Xylitol Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

356 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1, randomized, double-blind, placebo-controlled study1:1, randomized, double-blind, placebo-controlled study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 27, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xylitol wipes	Drug: Xylitol Xylitol dental wipes
Placebo Comparator: Placebo wipes	Other: Placebo Placebo dental wipes

Arm

Intervention/Treatment

Experimental: Xylitol wipes

Drug: Xylitol

Xylitol dental wipes

Placebo Comparator: Placebo wipes

Other: Placebo

Placebo dental wipes

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT04117477

Other Study ID Numbers:

2019-0261

First Posted:

Oct 7, 2019

Last Update Posted:

Sep 2, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cross Infection

Study Results

No Results Posted as of Sep 2, 2021