Xylitol Wipes for Bloodstream Infections in Stem Cell Transplant Patients

Recruiting at 2 trial locations

Overseen By Kelly McIntosh

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Recent oral radiation, Xylitol allergy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 33 days

419 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if xylitol wipes can prevent bloodstream infections in children and young adults undergoing stem cell transplants. These infections often occur when bacteria enter the bloodstream through damaged mouth tissues, a common issue post-transplant. Participants will be randomly assigned to use either xylitol wipes or grape-flavored placebo wipes twice a day. Eligible participants include patients aged 4 months to 25 years who plan to undergo a stem cell transplant at specific children’s hospitals and have at least one tooth. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, you must avoid chewing gum and toothpaste that contain xylitol during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that xylitol, a natural sweetener found in fruits and vegetables, has been safely used in foods since 1963. Studies have found that xylitol can improve oral health by reducing dental plaque and gum disease. People using xylitol wipes experienced fewer mouth ulcers. These findings suggest that xylitol is generally safe, with no major safety issues reported in these studies. This information supports the safety of xylitol for use in the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bloodstream infections, which often involve antibiotics, the investigational treatment using Xylitol wipes offers a unique approach. Xylitol, a sugar alcohol found naturally in fruits and vegetables, is being explored for its potential antimicrobial properties. Researchers are particularly interested because it may reduce the risk of infection without the side effects commonly associated with antibiotics. This makes it an exciting possibility for patients, especially those undergoing stem cell transplants who are more vulnerable to infections.

What evidence suggests that xylitol wipes might be an effective treatment for bloodstream infections?

This trial will compare the use of Xylitol wipes with grape-flavored placebo wipes in reducing the risk of bloodstream infections (BSIs) in stem cell transplant patients. Research has shown that xylitol wipes might help lower the risk of BSIs. Studies have found that these wipes can reduce dental plaque and gum disease, which are linked to these infections. By improving oral health, xylitol wipes may prevent harmful bacteria from entering the bloodstream through damaged areas in the mouth. Early results suggest that xylitol wipes could be a promising way to protect patients undergoing stem cell transplants from BSIs. While more research is needed, the initial evidence is encouraging. ^{1 2 3 4 5}

Who Is on the Research Team?

Christopher Dandoy, MD, MSc

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provide signed and dated informed consent and assent (when applicable) form

I am scheduled for a stem cell transplant at a specified hospital.

I agree not to use xylitol-containing gum or toothpaste during the study.

Exclusion Criteria

Known history of allergy to grapes or grape flavoring

I had radiation for cancer in my mouth, head, or neck within the last 6 months.

Known history of allergy to xylitol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive twice-daily intraoral xylitol-wipe or placebo application

33 days

Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Xylitol

Trial Overview 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.

How Is the Trial Designed?

Group I: Xylitol Experimental Treatment 1 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 Wipes Placebo Group 1 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.

Xylitol is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Xylitol for:

• Prevention of tooth decay
• Sugar substitute

Approved in European Union as Xylitol for:

• Prevention of tooth decay
• Sugar substitute

Approved in Canada as Xylitol for:

• Prevention of tooth decay
• Sugar substitute

Approved in Japan as Xylitol for:

• Prevention of tooth decay
• Sugar substitute

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

A study of 41 pediatric patients undergoing hematopoietic cell transplantation found a significant association between high dental caries risk and increased likelihood of bloodstream infections (BSI), with high-risk children being 21 times more likely to develop BSI.

The oral microbiome of children with high caries risk showed reduced microbial diversity and was enriched in cariogenic bacteria, suggesting that the presence of these bacteria may contribute to the risk of BSI in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental caries as a risk factor for bacterial blood stream infection (BSI) in children undergoing hematopoietic cell transplantation (HCT). Abduweli Uyghurturk, D., Lu, Y., Urata, J., et al.[2023]

The combination of xylitol, sodium fluoride (NaF), and zinc chloride (ZnCl2) effectively inhibited the growth of the bacteria S. Sobrinus OMZ 176 in a laboratory setting, suggesting a potential strategy for dental health.

The mechanism of action involves reduced glucose uptake and inhibition of glycolysis at key metabolic points, along with increased accumulation of xylitol metabolites, which together contribute to the suppression of bacterial growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined effect of xylitol, NaF and ZnCl2 on growth and metabolism of Streptococcus sobrinus OMZ 176. Scheie, AA., Assev, S., Rölla, G.[2019]

Xylitol demonstrates significant antimicrobial effects against Candida albicans, with a minimum inhibitory concentration (MIC) of 20 × 10^4 μg/mL and a minimum fungicidal concentration (MFC) of 40 × 10^4 μg/mL, indicating its potential to inhibit and kill the fungus.

The findings suggest that xylitol could be effectively incorporated into dental products like gums, toothpastes, and mouthwashes to help treat or prevent candidiasis, especially in individuals with compromised immune systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antifungal Activity of Xylitol against Candida albicans: An in vitro Study. Talattof, Z., Azad, A., Zahed, M., et al.[2019]

In a study of 10 patients undergoing allogeneic hematopoietic stem cell transplantation (ASCT), oral management, including dental treatments and hygiene instructions, was implemented to prevent bloodstream infections from oral bacteria, and no bacterial species were found in the blood during the observation period.

Despite all patients experiencing oral mucositis and periodontitis, the study provides microbiological evidence that effective oral management can help prevent bloodstream infections in ASCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of oral management in allogeneic hematopoietic stem cell transplantation recipients: microbiological evidence based on molecular analysis of oral bacteria. Kawajiri, J., Nagata, K., Nakamura, A., et al.[2021]

In a blinded randomized crossover trial involving healthy adolescents, xylitol tablets without red propolis (XT) were found to be effective in controlling harmful bacteria like Streptococcus spp. in dental biofilms, suggesting their potential for improving oral health.

Both xylitol tablets with (XPT) and without (XT) red propolis showed similar acceptability among participants, but XT had a higher purchase intention, indicating a preference for the simpler formulation despite propolis not enhancing the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of xylitol tablets with and without red propolis on salivary parameters, dental biofilm and sensory acceptability of adolescents: a randomized crossover clinical trial. Martins, ML., Monteiro, ASN., Vieira, TI., et al.[2021]

Xylitol effectively inhibits the growth of Streptococcus mutans in a dose-dependent manner, suggesting it could be useful in preventing dental caries caused by this bacteria.

The proposed mechanism for xylitol's effectiveness may involve its impact on glucose transport across the bacterial cell membrane, while sorbitol did not inhibit growth but only delayed bacterial growth phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth inhibition of Streptococcus mutans strain OMZ 176 by xylitol. Assev, S., Vegarud, G., Rölla, G.[2019]

Xylitol is a non-cariogenic sugar substitute that not only helps prevent cavities but also has a bacteriostatic effect against harmful bacteria like Strep mutans and Strep sanguis, which can take it up but cannot metabolize it.

The combination of xylitol and sorbitol enhances the anti-caries effect, as xylitol inhibits the metabolism of sorbitol by Strep mutans, making this combination both effective and cost-efficient, although high doses of xylitol can cause diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Xylitol, mechanisms of action and uses]. Wåler, SM., Rølla, G.[2013]

Xylitol crystals produced from corncob using the yeast Pichia caribbica are highly pure (>98%) and show no harmful contaminants that could affect mammalian cell growth.

In toxicity trials with female Wistar rats, xylitol demonstrated a high safety profile with an LD50 greater than 10,000 mg/kg, indicating it is safe for use as a food-grade ingredient pending further human trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food-grade xylitol production from corncob biomass with acute oral toxicity studies. Dasgupta, D., Ahuja, V., Singh, R., et al.[2023]

In a study involving pediatric hematopoietic stem cell transplantation (HSCT) recipients, daily xylitol wipes significantly improved oral health, reducing gingivitis, oral plaque, and ulcers compared to standard oral care.

The xylitol group experienced no bloodstream infections (BSIs) from oral organisms, while the standard care group had four cases, indicating that xylitol not only enhances oral hygiene but also effectively decreases the risk of serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Oral Health and Modulating the Oral Microbiome to Reduce Bloodstream Infections from Oral Organisms in Pediatric and Young Adult Hematopoietic Stem Cell Transplantation Recipients: A Randomized Controlled Trial. Badia, P., Andersen, H., Haslam, D., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05579639

Xylitol BSI Multisite - Reduction of Bloodstream Infections ... The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32505810/

Improving Oral Health and Modulating the Oral Microbiome to ... The aim of this study was to evaluate the impact of daily xylitol wipes in improving oral health, decreasing BSI from oral organisms, and modulating the oral ...

3. astctjournal.org astctjournal.org/article/S1083-8791(17)31409-X/fulltext

Impact of Xylitol on Oral Microbiome and Blood Stream ... Conclusions: The addition of Xylitol to oral standard care appears to decrease dental plaque, gingivitis and oral ulcerations in patients undergoing HSCT.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05579639/xylitol-bsi-multisite-reduction-of-bloodstream-infections-from-oral-organisms-in-pediatric-stem-cell-transplant

Xylitol BSI Multisite - Reduction of Bloodstream Infections ... The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04117477

Xylitol - Healthcare Associated Infection Reduction in Stem ... The overall objective of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial translocation through oral ...