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Search / Trial NCT06884748

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

Launched by MEDICAL COLLEGE OF WISCONSIN · Mar 13, 2025

Trial Information

Current as of May 09, 2025

Not yet recruiting

Keywords

Clostridioides Difficile Infection

ClinConnect Summary

This clinical trial is looking at whether a medication called Ursodeoxycholic Acid (UDCA) can help prevent the return of Clostridioides difficile (C. diff) colitis, a serious intestinal infection, when used alongside standard antibiotic treatments. Many people who are treated for C. diff experience a recurrence of the infection, so researchers want to see if UDCA can reduce this risk and also lower the need for repeated antibiotic use. The study will involve adults who are diagnosed with C. diff and have certain risk factors for it coming back. Participants will receive standard antibiotic treatment and take UDCA for up to eight weeks.

To be eligible for the study, participants must be at least 18 years old, have a positive test for C. diff, and require standard antibiotic treatment. Those with severe complications or other health issues, such as serious liver disease or who are pregnant, cannot take part. Throughout the trial, participants will be monitored closely for safety and any potential side effects, which may include mild stomach discomfort. This research could potentially lead to new ways to help patients recover from C. diff more effectively and reduce their reliance on antibiotics. The study will take place in Milwaukee, Wisconsin.

Gender

ALL

Eligibility criteria

  • 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.

About Medical College Of Wisconsin

The Medical College of Wisconsin (MCW) is a leading academic institution dedicated to advancing healthcare through innovative research, education, and clinical practice. As a prominent clinical trial sponsor, MCW is committed to conducting high-quality, ethically-guided research that aims to improve patient outcomes and address critical health challenges. Leveraging a multidisciplinary approach, MCW collaborates with a diverse network of healthcare professionals, researchers, and community partners to facilitate groundbreaking clinical trials across various medical fields, ensuring the translation of scientific discoveries into effective treatments and practices.

Locations

Milwaukee, Wisconsin, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported