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Xylitol Wipes for Bloodstream Infections in Stem Cell Transplant Patients

Phase 2
Recruiting
Led By Chris Dandoy, MD, MSc
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, 4 months to 25 years of age at the time of SCT (Day 0)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 days
Awards & highlights

Study Summary

This trial will evaluate if twice daily wipes with xylitol can reduce bloodstream infections in kids getting stem cell transplants, helping to prevent morbidity and mortality.

Who is the study for?
This trial is for children and young adults aged 4 months to 25 years who are undergoing stem cell transplantation. Participants must have at least one tooth, not use xylitol-containing products during the study, and be treated at specific hospitals. Those with allergies to grapes or xylitol, recent radiation treatment in the head or neck area, or those having a transplant without prior chemotherapy/radiation are excluded.Check my eligibility
What is being tested?
The trial tests if using xylitol wipes in the mouth twice daily can prevent bloodstream infections from oral bacteria in pediatric patients receiving stem cell transplants. It's a randomized study where some will get xylitol wipes and others a placebo, without knowing which they received.See study design
What are the potential side effects?
Xylitol is generally well-tolerated but may cause allergic reactions in rare cases. Since it's used orally as a wipe here, potential side effects might include local irritation or discomfort around the mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 months and 25 years old.
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I am scheduled for a stem cell transplant at a specified hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bacteremia from an oral organism
Secondary outcome measures
Bacteremia
Dental Plaque
Gingivitis
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: XylitolExperimental Treatment1 Intervention
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.
Group II: Grape-flavored WipesPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)NIH
298 Previous Clinical Trials
846,889 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiLead Sponsor
814 Previous Clinical Trials
6,531,162 Total Patients Enrolled
Chris Dandoy, MD, MScPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Media Library

Xylitol (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05579639 — Phase 2
Stem Cell Transplant Research Study Groups: Grape-flavored Wipes, Xylitol
Stem Cell Transplant Clinical Trial 2023: Xylitol Highlights & Side Effects. Trial Name: NCT05579639 — Phase 2
Xylitol (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579639 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria for this trial inclusive of individuals aged 35 and above?

"This study requests participants between the ages of 4 Months and 25 years old. Specifically, 226 trials are available for persons younger than 18 while 728 studies target those over 65."

Answered by AI

Who is able to access the opportunity of becoming a participant in this research?

"This clinical experiment requires 419 subjects aged 4 to 25 months that are willing and able to complete the necessary procedures, have undergone a stem cell transplant at one of 3 specified hospitals, possess at least one tooth, and abstain from any xylitol-containing gum or toothpaste during their participation. Moreover, all participants must sign an informed consent form."

Answered by AI

How potentially hazardous is Xylitol for people receiving treatment?

"Despite Xylitol receiving a score of 2, there is still limited data regarding its efficacy. To date, however, the compound has demonstrated some measure of safety in accordance with Phase 2 trial guidelines."

Answered by AI

Are there any opportunities to join this research project at the moment?

"According to the clinicaltrials.gov database, this experiment is not currently recruiting any new participants; it was first posted on November 1st 2022 and last edited on October 11th of that same year. However, many other trials are still actively seeking volunteers at this time with 911 options listed in total."

Answered by AI
~279 spots leftby Mar 2026