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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05579639
Phase
PHASE2
Status
Recruiting
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Conditions

  • Allogeneic Stem Cell Transplantation

Eligibility Criteria

Sex
ALL
Age
4 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Xylitol — OTHER
    Xylitol wipes
  • Placebo — OTHER
    Placebo wipes

Study Details

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.

Key Dates

Start date
Apr 4, 2023
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
419 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Xylitol
    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.
  • Placebo Comparator: Grape-flavored Wipes
    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.

Primary Outcome Measure

Bacteremia from an oral organism [ Time Frame: 33 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Vanessa Fabrizio
[email protected]
720-777-1982
Vanessa Fabrizio, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber/Boston Children'sBostonMassachusetts02115
Leslie Lehmann, MD
[email protected]
617-632-3352
Paola Tabares
[email protected]
Leslie Lehmann, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Kelly McIntosh
[email protected]
513-803-0460
Christopher Dandoy, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, CODana-Farber/Boston Children's· Boston, MACincinnati Children's Hospital Medical Center· Cincinnati, OH

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