Xylitol for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether xylitol, a sugar substitute, can safely and effectively clear C. difficile, a harmful gut bacterium, in people with inflammatory bowel disease (IBD). Researchers will test two different doses of xylitol against a placebo (a substance with no active ingredient) to determine which works best. The trial is open to individuals diagnosed with IBD, such as Crohn's disease or ulcerative colitis, who have mild symptoms and are attending a colonoscopy or clinic visit. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those with chronic use of antibiotics, which might suggest some restrictions on certain medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that xylitol is under study for its safety and effectiveness in treating certain gut issues, such as inflammatory bowel disease (IBD). Some studies suggest that xylitol can improve gut health without worsening IBD symptoms and might even help reduce inflammation in the colon. However, high doses of xylitol may not be safe, as they could lead to problems over time, including the risk of tumor growth. Lower doses tested in mice have shown positive changes in gut bacteria.
As this study is in its early stages, it primarily focuses on understanding xylitol's safety for humans. Researchers are still collecting initial safety data. Participants in this study will help determine if xylitol is well-tolerated by people with IBD.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for inflammatory bowel disease (IBD), which often include anti-inflammatory drugs, immunosuppressants, and biologics, Xylitol offers a unique approach. Xylitol is a natural sugar alcohol that researchers believe can potentially reduce inflammation in the gut. It's exciting because it could offer a novel mechanism of action by modulating gut microbiota, which is different from how current medications work. Additionally, being a dietary supplement, Xylitol might provide a more accessible and potentially safer option with fewer side effects compared to traditional IBD drugs.
What evidence suggests that this trial's treatments could be effective for inflammatory bowel disease?
Research suggests that xylitol might help with symptoms of inflammatory bowel disease (IBD). Studies on mice have shown that xylitol can improve the balance of beneficial bacteria in the gut, which is important for gut health. This improvement may help reduce inflammation in the intestines. Additionally, researchers are studying xylitol for its potential to remove harmful bacteria like C. difficile, which can cause serious gut infections. These early findings indicate that xylitol could be a promising option for people with IBD. In this trial, participants will receive either Dose A or Dose B of xylitol, or a placebo, to further investigate its effects.23567
Who Is on the Research Team?
Jessica Allegretti, MD, MPH
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Inflammatory Bowel Disease (IBD), including Crohn's disease, ulcerative colitis, or indeterminate colitis. Participants must be scheduled for an outpatient colonoscopy and willing to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo or one of two doses of xylitol for 4 weeks
Follow-up
Participants are monitored for safety, efficacy, and disease activity through week 52
What Are the Treatments Tested in This Trial?
Interventions
- Sucralose
- Xylitol
Trial Overview
The study tests if xylitol can help remove C. difficile bacteria in IBD patients compared to a placebo (sucralose). Patients are randomly chosen to get either xylitol or sucralose in capsule form twice daily for four weeks, with follow-up testing up to one year.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Patients in this are will be receiving 15g/day of Xylitol over a 4 week period.
Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.
Patients in this arm will be receiving placebo over a 4 week period.
Sucralose is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Food additive
- Food additive
- Food additive
- Food additive
- Food additive
- Food additive
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Published Research Related to This Trial
Citations
Using gut microbiota and non-targeted metabolomics ...
Conclusions: Our findings suggest that xylitol can help improve IBD symptoms. Xylitol can improve the intestinal flora of IBD mice and increase ...
Xylitol Use for Decolonization of C. Difficile in Patients With ...
This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C.
Xylitol for Inflammatory Bowel Disease Β· Info for Participants
A 6-week low FODMAP diet (LFD) was found to be safe for patients with inflammatory bowel disease (IBD) and led to significant improvements in disease activity, ...
Using gut microbiota and non-targeted metabolomics ...
Conclusions. Our findings suggest that xylitol can help improve IBD symptoms. Xylitol can improve the intestinal flora of IBD mice and increase ...
Xylitol Use for Decolonization of C. Difficile in Patients With IBD
This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C.
Xylitol β Uses, Side Effects, and More
Taking high doses of xylitol is possibly unsafe. Using very high doses long-term might cause tumors. When used as a rinse in the nose: Xylitol is possibly safe ...
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medchemexpress.com
medchemexpress.com/xylitol.html?srsltid=AfmBOooYWsC5vzkWfl-syJFyKnhLw9fdAs_Y1vyevUvq-3AYZXAWL2X8Xylitol (Synonyms: Xylite) - Sugar Alcohol
Result: Low-dose (40 mg/kg) and medium-dose (194 mg/kg): significantly altered the composition of fecal microbiota in mice.
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