Xylitol for Stem Cell Transplant

Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Stem Cell TransplantXylitol - Other
4 - 25
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Allogeneic Stem Cell Transplant

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 33 days

33 days
Bacteremia from an oral organism
Dental Plaque
Objective mucositis
Oral microbiome diversity
Patient-reported mucositis

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

1 of 2
Grape-flavored Wipes
1 of 2

Experimental Treatment

Non-Treatment Group

419 Total Participants · 2 Treatment Groups

Primary Treatment: Xylitol · Has Placebo Group · Phase 2

Experimental Group · 1 Intervention: Xylitol · Intervention Types: Other
Grape-flavored Wipes
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 33 days

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
771 Previous Clinical Trials
5,423,861 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
286 Previous Clinical Trials
806,770 Total Patients Enrolled
Christopher Dandoy, MD, MScPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Chris Dandoy, MD, MScPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Eligibility Criteria

Age 4 - 25 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have at least one tooth.
You must not use gum or toothpaste that contains xylitol during the study.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.