PREVENTION OF RECURRENCE OF CLOSTRIDIOIDES DIFFICILE COLITIS WITH URSODEOXYCHOLIC ACID (UCDA) AS A SUPPLEMENT TO STANDARD THERAPY
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Lack of recurrent C. difficile recurrence
Study Overview
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.
Detailed Description
Prevention of Recurrence of Clostridioides Difficile Colitis with
Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Paraj D. Patel M.D, Daniel J. Stein, M.D, Helmut V. Ammon, MD
This proposal describes the use of UDCA as an adjunct to standard treatment of C. difficile (C. diff) colitis for the prevention of recurrence of the disease.
The Problem: C. diff colitis is a serious burden on the healthcare system. In 2011 there were close to 500,000 cases of and 29,000 deaths from C. diff. colitis reported in the US at an annual cost of 58 billion dollars [1, 2] Treatment consists of Vancomycin or Fidaxomicin [3]. The recurrence rate is between 7% and 20% within 2 months [1, 4]. The risk of recurrence increases with each episode and various risk factors to up to 46% in the presence of more than 3 risk factors[5, 6]. Current efforts to deal with this problem include prolonged treatment with antibiotics, fecal microbiota transplants, probiotics, and monoclonal antibodies [7] .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Life expectancy < 6 months; fulminant colitis; ileus; decompensated liver disease; pregnancy and lactating females; Inability to give informed consent.
Arms & Interventions
UDCA Arm
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.
Intervention: Ursodiol 500 MG (Drug)
Outcomes
Primary Outcomes
Lack of recurrent C. difficile recurrence
Time Frame: 8 weeks and 3 months
Absence of recurrent C. difficile recurrence based on symptoms and standard of care testing at 3 months and repeat stool testing at 8 weeks.
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Stein
Professor
Medical College of Wisconsin