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Could a sweetener stop deadly infections in transplant kids?

NCT ID NCT05579639

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tests whether a special wipe containing xylitol, a natural sweetener, can reduce dangerous bloodstream infections in children and young adults undergoing stem cell transplants. These infections often start from bacteria in the mouth and can be life-threatening. Participants will be randomly assigned to receive either the xylitol wipe or a placebo wipe twice daily during their hospital stay.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

256 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 months to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

gingivitis mucositis Plaque, Amyloid Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allogeneic stem cell transplantation

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Dana-Farber/Boston Children's

    Boston, Massachusetts, 02115, United States

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