Allogeneic Stem Cell TransplantationPhase 2NCT05579639
Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant
A Phase 2 study testing Xylitol in people with Allogeneic Stem Cell Transplantation, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 months to 25 years
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- What is being tested?
- Xylitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Apr 2023to 11 Sep 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Dana-Farber/Boston Children's
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant: a Randomized, Multicenter, Double-blind , Placebo-controlled Study Evaluating Twice Daily Oral Xylitol
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.
Read the detailed description
Patients will be randomized to receive either twice-daily intraoral grape-flavored xylitol-wipe (intervention arm) or grape-flavored saline wipe (control arm) application in addition to the current standard of care (SOC). The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ulcers in the mouth), or gingivitis in patients who undergo allogeneic stem cell transplant (SCT).
- Conditions
- Allogeneic Stem Cell Transplantation
- Being tested
- Xylitol, Placebo
- Keywords
- bloodstream infections, oral health, xylitol, dental health, gingivitis, mucositis, plaque
- Medical subject headings
- Sepsis, Gingivitis, Mucositis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylitolOther
Also called Spiffies Xylitol Wipes
Xylitol wipes
PlaceboOther
Also called Grape-Flavored Wipes
Placebo wipes
| Study group | Role | What they receive |
|---|---|---|
| Xylitol | Experimental | 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. Receives: Other: Xylitol |
| Grape-flavored Wipes | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteremia from an oral organism
Incidence of bloodstream infection (BSI) from oral flora organisms in in patients receiving xylitol compared to placebo
Measured: 33 days
Secondary outcomes (6)
Bacteremia from other non-oral flora organisms
Incidence of BSI from non-oral flora organisms in patients receiving xylitol compared to placebo
Measured: 33 days
Dental plaque
Debris Index Simplified (DI-S) score
Measured: 33 days
Gingivitis
Mean Modified Gingival Index (MGI) score
Measured: 33 days
Objective mucositis
Mean Oral Mucositis Assessment Scale (OMAS) score
Measured: 33 days
Patient-reported mucositis
ChIMES total score
Measured: 33 days
Oral microbiome diversity
Shannon Diversity Index
Measured: 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start4 Apr 2023
- Primary completion11 Sep 2026
- Study completion11 Sep 2026
Why it stopped: At the recommendation of the DSMB, the study was halted following an interim futility analysis, which determined that continued enrollment would not alter the study outcome.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, multicenter, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Christopher Dandoy, MD, MSc, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579639
- Sponsor's protocol ID
- 2021-0537
- Other IDs
- 1UG3DE030401-01
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No