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

Last updated: March 5, 2025
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

2

Condition

Allo-hematopoietic Stem Cell Transplant

Soft Tissue Infections

Allogeneic Hematopoietic Stem Cell Transplant

Treatment

Placebo

Xylitol

Clinical Study ID

NCT05579639
2021-0537
1UG3DE030401-01
  • Ages 4-25
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thestudy

  • Admitted and planning to undergo an allogeneic stem cell transplant (SCT) atCincinnati 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 theintervention period

Exclusion

Exclusion Criteria:

  • Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6months 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 notreceive any chemotherapy or radiation prior to stem cell infusion)

Study Design

Total Participants: 419
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 04, 2023
Estimated Completion Date:
June 30, 2027

Study 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 allogeneic stem cell transplant (SCT).

Connect with a study center

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Dana-Farber/Boston Children's

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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