Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant

Cincinnati Children's Hospital Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Allogeneic Stem Cell Transplantation

Treatments: Other: Xylitol; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05579639

2021-0537

1UG3DE030401-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable population. The investigators will conduct a randomized, double-blind, placebo-controlled trial at three institutions to evaluate the effectiveness of twice daily intraoral xylitol-wipe application on reducing BSI in pediatric SCT patients.

Full description

Patients will be randomized to receive either twice-daily intraoral grape-flavored xylitol-wipe (intervention arm) or grape-flavored saline wipe (control arm) application in addition to the current standard of care (SOC). The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ulcers in the mouth), or gingivitis in patients who undergo hematopoietic stem cell transplant.

Enrollment: 419 estimated patients

Sex: All

Ages: 4 months to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide signed and dated informed consent and assent (when applicable) form
• Willing to comply with all study procedures and be available for the duration of the study
• Admitted and planning to undergo an allogeneic stem cell transplant (SCT) at Cincinnati Children's Hospital Medical Center (CCHMC), Boston Children's Hospital, or Children's Hospital of Colorado (Denver).
• Male or female, 4 months to 25 years of age at the time of SCT (Day 0)
• Have a minimum of one tooth
• Agree to avoid chewing gum and toothpaste that contains xylitol during the intervention period

Exclusion criteria

• Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6 months per the study participant's medical record
• Cranial boost in patients receiving total body irradiation
• Known history of allergy to xylitol
• Known history of allergy to grapes or grape flavoring
• Undergoing a conditioning-free allogeneic stem cell transplant (patient does not receive any chemotherapy or radiation prior to stem cell infusion)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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419 participants in 2 patient groups, including a placebo group

Xylitol

Experimental group

Description:

Xylitol, a naturally occurring sugar alcohol found in plums, strawberries, and various vegetables such as cauliflower, has been approved for use in food by the US FDA since 1963. Spiffies Xylitol Wipes will be used.

Treatment:

Other: Xylitol

Grape-flavored Wipes

Placebo Comparator group

Description:

Grape-flavored wipes will be used with 2 drops of PCCA colorless grape flavoring. The grape-flavored wipes each contain a solution of 0.9% Sodium Chloride, purified water, and Benzalkonium chloride. PCCA artificial colorless grape flavoring will be used. The PCCA grape flavoring contains propylene glycol, ethyl alcohol, and artificial flavoring.

Treatment:

Other: Placebo