Xylitol for Inflammatory Bowel Disease

Overseen By Heidy Cabral

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Brigham and Women's Hospital

Must not be taking: Antibiotics

Disqualifiers: Colectomy, Ostomy, J-pouch, others

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

99 Participants Needed

Trial Summary

What is the purpose of this trial?

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. difficile in IBD patients. A total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. All arms will receive an identical capsule dosing for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.

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.

What data supports the effectiveness of the treatment Xylitol for Inflammatory Bowel Disease?

There is no direct evidence from the provided research articles that supports the effectiveness of Xylitol specifically for treating Inflammatory Bowel Disease. However, dietary interventions, in general, have been shown to have some benefits in managing symptoms of IBD, and further studies are needed to explore the potential role of specific dietary components like Xylitol. ^{1 2 3 4 5}

How is the treatment with Xylitol and Sucralose different from other treatments for inflammatory bowel disease?

This treatment is unique because it involves dietary components, Xylitol and Sucralose, which are not standard drugs for inflammatory bowel disease. Traditional treatments often include medications like salicylates and steroids, while this approach focuses on dietary support, which is an emerging area of research for managing conditions like Crohn's disease and ulcerative colitis. ^{3 6 7 8 9}

Research Team

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), 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

I am 18 years old or older.

I have been diagnosed with a form of inflammatory bowel disease.

I am scheduled for an outpatient colonoscopy.

Exclusion Criteria

I cannot follow the study's required procedures.

Allergy to xylitol or sucralose

I have had surgery on my colon, such as a colectomy, ostomy, J-pouch, or other, but not an appendectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either placebo or one of two doses of xylitol for 4 weeks

4 weeks

1 visit (in-person) at baseline

Follow-up

Participants are monitored for safety, efficacy, and disease activity through week 52

48 weeks

Visits at week 4, 8, 26, and 52

Treatment Details

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.

Participant Groups

Group I: Dose B of Xylitol Experimental Treatment 1 Intervention

Patients in this are will be receiving 15g/day of Xylitol over a 4 week period.

Group II: Dose A of Xylitol Experimental Treatment 1 Intervention

Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.

Group III: Placebo Placebo Group 1 Intervention

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:

Approved in European Union as Sucralose for:

• Food additive

Approved in United States as Sucralose for:

• Food additive

Approved in Canada as Sucralose for:

• Food additive

Approved in Japan as Sucralose for:

• Food additive

Approved in China as Sucralose for:

• Food additive

Approved in Switzerland as Sucralose for:

• Food additive

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

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, as indicated by a decrease in the Harvey-Bradshaw index.

The LFD also resulted in a notable reduction in fecal calprotectin levels, a marker of inflammation, and showed a slight improvement in quality of life for patients, suggesting its potential benefits even in those with mild disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, 6-wk trial of a low FODMAP diet in patients with inflammatory bowel disease. Bodini, G., Zanella, C., Crespi, M., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dietary xylo-oligosaccharide ameliorates colonic mucus microbiota penetration with restored autophagy in interleukin-10 gene-deficient mice. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, 6-wk trial of a low FODMAP diet in patients with inflammatory bowel disease. [2020]

3. England pubmed.ncbi.nlm.nih.gov

New treatments in inflammatory bowel disease. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary Interventions for the Treatment of Inflammatory Bowel Diseases: An Updated Systematic Review and Meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Chronic inflammatory bowel diseases and nutrition]. [2006]

6. Germany pubmed.ncbi.nlm.nih.gov

Diet supporting therapy for inflammatory bowel diseases. [2023]

7. Mexico pubmed.ncbi.nlm.nih.gov

[Epidemiology and clinical characteristics of ulcerative colitis in north-eastern Mexico]. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Ethnicity Influences Risk of Inflammatory Bowel Disease (IBD)-Associated Colon Cancer: A Cross-sectional Analysis of Dysplasia Prevalence and Risk Factors in Hispanics and Non-Hispanic Whites With IBD. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Asperuloside suppressing oxidative stress and inflammation in DSS-induced chronic colitis and RAW 264.7 macrophages via Nrf2/HO-1 and NF-κB pathways. [2021]