180 Participants Needed

Xylitol for C. Difficile

HC
JA
Overseen ByJessica Allegretti, MD MPH
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who are on chronic antibiotics.

What data supports the effectiveness of the treatment Xylitol for C. Difficile?

Research shows that xylitol can reduce the ability of C. difficile bacteria to stick to intestinal cells, which might help prevent infections. In animal studies, xylitol also increased survival rates and reduced gut colonization by C. difficile.12345

Is xylitol safe for humans?

Xylitol is generally considered safe for humans and is commonly used as a sugar substitute. However, it is highly toxic to dogs, causing serious health issues like liver failure and low blood sugar.678910

How does the treatment Xylitol differ from other treatments for C. difficile infection?

Xylitol is unique because it works by preventing C. difficile bacteria from sticking to the gut lining, which can help stop the infection from taking hold. This approach is different from traditional antibiotics, which kill bacteria but can also lead to resistance and recurrence.12111213

Research Team

JA

Jessica Allegretti, MD MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults over 18 with Inflammatory Bowel Disease (IBD) who are coming in for a colonoscopy or clinic visit. They should have inactive or mild IBD, as shown by specific low disease scores. People can't join if they use antibiotics often, had certain gut surgeries, can't swallow pills, or are allergic to xylitol.

Inclusion Criteria

Signed informed consent
I am scheduled for an outpatient colonoscopy or clinic visit.
My inflammatory bowel disease is mild or inactive.
See 2 more

Exclusion Criteria

I regularly take antibiotics for a long-term condition.
I am unable to give my consent.
I have had surgery on my colon, such as a colectomy, ostomy, or J-pouch.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive daily doses of xylitol for 7 days in one of five dosing groups

1 week
1 visit (in-person), weekly phone calls

Follow-up

Participants are monitored for safety, efficacy, and clinical outcomes, including C. difficile decolonization and IBD activity

26 weeks
Assessments at Week 8 and Week 26

Treatment Details

Interventions

  • Xylitol
Trial OverviewThe trial is testing the safety and effectiveness of xylitol, a sugar alcohol used as a sweetener, to remove C. difficile bacteria from the gut in people with IBD. It's an early-stage study where participants will take increasing doses of xylitol orally.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Dose Finding CohortExperimental Treatment1 Intervention
One of five consecutively increasing dosing groups of xylitol
Group II: Observational CohortActive Control1 Intervention
Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Findings from Research

In a pooled analysis of the MODIFY I and II trials involving patients with recurrent Clostridium difficile infection (rCDI), bezlotoxumab treatment was associated with a reduction in cumulative inpatient-days, averaging 12.1 days compared to 14.1 days for the placebo group over an 84-day follow-up period.
The reduction in inpatient-days was more pronounced in patients with multiple risk factors for rCDI, indicating that bezlotoxumab may significantly decrease healthcare resource use for those at higher risk.
Bezlotoxumab Is Associated With a Reduction in Cumulative Inpatient-Days: Analysis of the Hospitalization Data From the MODIFY I and II Clinical Trials.Basu, A., Prabhu, VS., Dorr, MB., et al.[2022]
C. difficile infections are on the rise in developed countries due to factors like antibiotic overuse and the emergence of new strains, highlighting the urgent need for better treatment options.
The review discusses both current treatments and promising new agents in development, focusing on antibiotics that may offer improved efficacy, selectivity, and reduced side effects compared to existing therapies.
Progress in the discovery of treatments for C. difficile infection: A clinical and medicinal chemistry review.Tsutsumi, LS., Owusu, YB., Hurdle, JG., et al.[2021]

References

Inhibition of adhesion of Clostridium difficile to Caco-2 cells. [2020]
A combination of the probiotic and prebiotic product can prevent the germination of Clostridium difficile spores and infection. [2020]
Bezlotoxumab Is Associated With a Reduction in Cumulative Inpatient-Days: Analysis of the Hospitalization Data From the MODIFY I and II Clinical Trials. [2022]
Investigational new treatments for Clostridium difficile infection. [2020]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Progress in the discovery of treatments for C. difficile infection: A clinical and medicinal chemistry review. [2021]
Assessment of xylitol serum levels during the course of parenteral nutrition including xylitol in intensive care patients: a case control study. [2014]
Xylitol toxicity in dogs. [2013]
Acute Hepatic Failure in a Dog after Xylitol Ingestion. [2018]
Perspectives on xylitol-induced oral effects. [2013]
Safety evaluation and maximum use level for transient ingestion in humans of allitol. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of cycloserine-cefoxitin fructose agar (CCFA), CCFA with horse blood and taurocholate, and cycloserine-cefoxitin mannitol broth with taurocholate and lysozyme for recovery of Clostridium difficile isolates from fecal samples. [2021]
Lauric Acid Is an Inhibitor of Clostridium difficile Growth in Vitro and Reduces Inflammation in a Mouse Infection Model. [2023]
Identification of novel p-cresol inhibitors that reduce Clostridioides difficile's ability to compete with species of the gut microbiome. [2023]