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

Allogeneic Stem Cell Transplantation Clinical Trial

Official title:

Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant: a Randomized, Multicenter, Double-blind , Placebo-controlled Study Evaluating Twice Daily Oral Xylitol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579639
• Other study ID #: 2021-0537
• Secondary ID: 1UG3DE030401-01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 4, 2023
• Est. completion date: June 2027

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Kelly McIntosh
• Phone: 513-803-0460
• Email: Kelly.McIntosh[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 419
• Est. completion date: June 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation
• Infections
• Sepsis

Intervention

Other:
• Xylitol
Xylitol wipes
• Placebo
Placebo wipes

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Dana-Farber/Boston Children's	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bacteremia from other non-oral flora organisms	Incidence of BSI from non-oral flora organisms in patients receiving xylitol compared to placebo	33 days
Secondary	Dental plaque	Debris Index Simplified (DI-S) score	33 days
Secondary	Gingivitis	Mean Modified Gingival Index (MGI) score	33 days
Secondary	Objective mucositis	Mean Oral Mucositis Assessment Scale (OMAS) score	33 days
Secondary	Patient-reported mucositis	ChIMES total score	33 days
Secondary	Oral microbiome diversity	Shannon Diversity Index	33 days