Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy

NCT06884748 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: PRO00049268
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether Ursodeoxycholic Acid (UDCA) can help prevent recurrence of Clostridioides difficile (C. diff) colitis when used along with standard antibiotic treatment. C. diff colitis is a serious infection that can return after treatment, and researchers want to see if UDCA can reduce this risk. This study aims to answer three main questions. First, can UDCA help prevent C. diff from returning after standard treatment? Second, does adding UDCA to treatment lower the need for repeated antibiotic use? Third, is UDCA safe and well-tolerated for people with C. diff? Participants in the study will be adults diagnosed with C. diff colitis who have risk factors for recurrence. Each participant will receive standard antibiotic treatment, which may include Vancomycin, Fidaxomicin, or Metronidazole. In addition to their antibiotic therapy, participants will take UDCA at a dose of 500 mg three times a day for up to eight weeks. If a participant's stool test shows they are C. diff negative at four weeks, they will stop taking UDCA early. Researchers will monitor participants throughout the study. Stool samples will be tested at the beginning, after four weeks, and at the end of the study. If a participant develops diarrhea, a stool test will check for C. diff. If C. diff is negative, the UDCA dose will be reduced. Weekly phone calls will be made to check for side effects and ensure participants are following the treatment plan. C. diff colitis is a common and serious infection, with up to 46 percent of high-risk patients experiencing recurrence. Current treatments rely on antibiotics, which can disrupt gut bacteria and increase the risk of reinfection. UDCA is a naturally occurring bile acid that may help prevent C. diff from growing, reducing the need for repeated antibiotic treatment. If successful, this study could introduce a new way to prevent C. diff from coming back, helping patients recover more effectively while reducing antibiotic use. Eligible participants must be at least 18 years old, have a positive C. diff test, and be receiving standard antibiotic treatment for C. diff. People who have severe or life-threatening C. diff colitis, a life expectancy of less than six months, serious liver disease, or are pregnant or breastfeeding will not be eligible to participate. UDCA is FDA-approved and has been used safely for decades in liver diseases and gallstone treatment. Some people may experience mild side effects, such as diarrhea, nausea, or stomach discomfort. Participants will be closely monitored for safety throughout the study. This trial will take place within the Froedtert and Medical College of Wisconsin healthcare system in Milwaukee, Wisconsin.

Conditions

Clostridioides Difficile Infection

Keywords

Clostridioides difficile infection

Outcome Measures

Primary Outcomes (1)

• Lack of recurrent C. difficile recurrence

  Absence of recurrent C. difficile recurrence based on symptoms and standard of care testing at 3 months and repeat stool testing at 8 weeks.

  8 weeks and 3 months

Study Arms (1)

UDCA Arm

EXPERIMENTAL

Standard of care treatment (Flagyl, Vancomycin or Fidaxomicin) + UDCA 500 mg TID for 8 weeks. UDCA to be started while patient is on antibiotics for C. difficile and continue for 8 weeks total.

Drug: Ursodiol 500 MG

Interventions

Ursodiol 500 MG DRUG

Standard of care treatment (Flagyl, Vancomycin or Fidaxomicin) + UDCA 500 mg TID for 8 weeks. UDCA to be started while patient is on antibiotics for C. difficile and continue for 8 weeks total.

UDCA Arm

Eligibility Criteria

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

You may qualify if:

• Eligible patients: C. diff. toxin +ve patients \> 18 years with one or more risk factors for recurrence \[6,7\] requiring standard treatment with Flagyl, Vancomycin or fidaxomicin.

You may not qualify if:

• Life expectancy \< 6 months; fulminant colitis; ileus; decompensated liver disease; pregnancy and lactating females; Inability to give informed consent.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Daniel Stein

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Central Study Contacts

Daniel Stein, MD

CONTACT

14149556858; dstein@mcw.edu

Helmut Ammon, MD

CONTACT

4149556858; hammon@mcw.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)