Phase 4
Completed N=9
C. Difficile and Ursodiol
Source: ClinicalTrials.gov NCT02748616 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern — 100 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid composition (80% deoxycholic acid) to maintain growth suppression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern |
100 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients with recurrent C. difficile colitis
- 18 years of age and older
- Capable of giving informed consent
Exclusion Criteria
- Patients with other gastrointestinal problems prone to cause diarrhea if they cannot be controlled for the period of the study. Lactose intolerance or gluten enteropathy are not an exclusion provide that the potential subject is asymptomatic and can be expected to adhere to the appropriate dietary regimen.
- Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets or components of the formulations.
- Patients not available for long-term follow-up (2 months) by their physician will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT02748616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.