Ursodeoxycholic Acid for C. diff Infection
(PREVENT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you will continue your standard antibiotic treatment for C. diff while taking the study medication, UDCA.
What data supports the effectiveness of the drug Ursodeoxycholic Acid (UDCA) for C. diff infection?
Research suggests that Ursodeoxycholic Acid (UDCA) can inhibit the growth of Clostridium difficile, the bacteria responsible for C. diff infections, and may help prevent related conditions like ileal pouchitis. Additionally, UDCA has been shown to have various beneficial properties, such as protecting liver cells and dissolving gallstones, which indicate its broad therapeutic potential.12345
Is ursodeoxycholic acid (UDCA) generally safe for humans?
Ursodeoxycholic acid (UDCA) is generally considered safe for treating certain liver conditions, with few side effects at standard doses. However, high doses have been linked to serious side effects, including liver damage and increased risk of liver cancer, especially in certain conditions like primary sclerosing cholangitis.35678
How does the drug ursodeoxycholic acid differ from other treatments for C. diff infection?
Ursodeoxycholic acid (UDCA) is unique because it inhibits the growth of C. diff bacteria and prevents recurrence of related conditions, unlike standard antibiotics that only target active infections. It is a bile acid that also has protective effects on liver cells, making it different from typical treatments for C. diff.13456
What is the purpose of this trial?
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.
Eligibility Criteria
Adults with a positive C. diff test currently receiving standard antibiotics for C. diff colitis can join this trial. It's not for those with severe or life-threatening C. diff, serious liver disease, less than six months to live, or who are pregnant/breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard antibiotic treatment plus UDCA 500 mg three times a day for up to eight weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with stool tests at 4 and 8 weeks
Treatment Details
Interventions
- Ursodeoxycholic Acid (UDCA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor