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

NCT05579639 | Recruiting Phase 2 DMC

• 2 other identifiers: 2021-05371UG3DE030401-01
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Allogeneic Stem Cell Transplantation

Keywords

bloodstream infections; oral health; xylitol; dental health; gingivitis; mucositis; plaque

Outcome Measures

Primary Outcomes (1)

• Bacteremia from an oral organism

  Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo

  33 days

Secondary Outcomes (6)

• Bacteremia from other non-oral flora organisms

  33 days

• Dental plaque

  33 days

• Gingivitis

  33 days

• Objective mucositis

  33 days

• Patient-reported mucositis

  33 days

Study Arms (2)

Xylitol

EXPERIMENTAL

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.

Other: Xylitol

Grape-flavored Wipes

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Xylitol OTHER

Xylitol wipes

Also known as: Spiffies Xylitol Wipes

Xylitol

Placebo OTHER

Placebo wipes

Also known as: Grape-Flavored Wipes

Grape-flavored Wipes

Eligibility Criteria

• Age: 4 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (3)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Dana-Farber/Boston Children's

Boston, Massachusetts, 02115, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Sepsis; Gingivitis; Mucositis; Plaque, Amyloid

Interventions

Xylitol

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Christopher Dandoy, MD, MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly McIntosh

CONTACT

513-803-0460; Kelly.McIntosh@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, parents/guardians, nursing staff (interventionists), oral evaluators, and investigators will be blinded to the intervention, administered in the form of twice-daily grape-flavored xylitol wipes or grape-flavored saline wipes (controls). Preformed packets will be prepared by CCHMC Investigational Pharmacy staff, which will consist of either saline wipes with natural grape flavoring or xylitol. The color, taste, and smell of the wipes will be identical. The statistician will be unblinded to treatment assignment for the analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, multicenter, double-blind, placebo-controlled

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: April 4, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)