Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients

Cincinnati Children's Hospital Medical Center

Status and phase: Terminated; Phase 2

Conditions: Allogeneic Hematopoietic Cell Transplantation

Treatments: Other: Placebo; Drug: Xylitol

Study type: Interventional

Funder types: Other

Identifiers

NCT04117477

2019-0261

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 46 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Xylitol wipes

Experimental group

Treatment:

Drug: Xylitol

Placebo wipes

Placebo Comparator group

Treatment:

Other: Placebo