Xylitol Wipes for Bloodstream Infections in Stem Cell Transplant Patients

Phase 2

Recruiting

Led By Christopher 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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 33 days

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 33 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bacteremia from an oral organism

Secondary study objectives

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.

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