Diarrhea
Conditions
Keywords
Colitis, Bile
Brief 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.
Detailed description
The non-investigational reference therapies, Metronidazole, Vancomycin and fidaxomicin , are FDA-approved antibiotics currently in use today because of their effectiveness in suppressing the growth of C. difficile and therefore quickly eliminating the colitis and diarrhea. However, they do not promote the restoration of the normal bacterial flora. Therefore, when medication is stopped, the C. difficile colitis returns. In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence.
Interventions
DRUGUrsodiol
Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern | 2 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ursodiol Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.
Ursodiol: Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did Not Complete Ursodial Course | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Ursodiol |
|---|---|
| Age, Continuous | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ursodiol | Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern | 100 percentage of participants |