UDCA added to standard therapy to prevent C. diff recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial examines UDCA as a supplement to usual antibiotic treatment for C. difficile colitis. Adults with toxin-positive disease and recurrence risk factors receive standard antibiotics (vancomycin, fidaxomicin, or metronidazole) plus UDCA 500 mg three times daily for up to eight weeks. The goal is to see if UDCA lowers recurrence rates, reduces need for repeated antibiotics, and remains safe and tolerable. The study focuses on whether modifying bile acids can influence recurrence dynamics in this infection. Primary outcomes include recurrence prevention and safety signals related to UDCA co-administration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Daniel Stein
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Daniel Stein, MD
• Email: dstein@mcw.edu
• Phone: 14149556858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.