Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease

NCT06799039 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2025P000210
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD); Clostridioides Difficile Infection

Keywords

C. Difficile; Decolonization; IBD

Outcome Measures

Primary Outcomes (2)

• Safety and Efficacy of Xylitol

  Incidence of Treatment Emergent Adverse Events (TEAEs) through Week 8

  8 weeks

• C. Diff Decolonization

  Proportion of patients decolonized of C. difficile at Week 8

  8 weeks

Secondary Outcomes (3)

• Biomass of C. Difficile

  8 weeks

• Effect of C. difficile decolonization on Inflammatory Bowel Disease (IBD) clinical outcomes

  26 weeks

• C. Difficile infection surveillance

  26 weeks

Study Arms (2)

Dose Finding Cohort

EXPERIMENTAL

One of five consecutively increasing dosing groups of xylitol

Drug: Xylitol

Observational Cohort

NO INTERVENTION

Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring.

Interventions

Xylitol DRUG

Xylitol is a sugar alcohol and considered a GRAS substance by the FDA. Patients will be consecutively enrolled into one of five dosing including 1g, 2g, 5g, 7g and 9g.

Dose Finding Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Male or female ≥ 18 years of age
• IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
• Inactive or mild IBD (HBI score ≤ 4; Partial Mayo score ≤ 4)
• Presenting for outpatient colonoscopy or clinic appointment

You may not qualify if:

• Unable to provide consent.
• Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)
• Unable to complete study procedures.
• Chronic use of antibiotics.
• Inability or unwillingness to swallow capsules.
• Allergy to xylitol.
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Clostridium Infections

Interventions

Xylitol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Jessica Allegretti, MD MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidy Cabral

CONTACT

617-525-7322; hjcabral@bwh.harvard.edu

Jessica Allegretti, MD MPH

CONTACT

617-732-6389

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jessica R. Allegretti, MD, MPH, FACG, AGAF, Principle Investigator

Model Details: Dose Finding

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)