C. Difficile and Ursodiol

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02748616
• Date of registration: 20/04/2016
• Prospective Registration: Yes
• Primary sponsor: NYU Langone Health
• Public title: C. Difficile and Ursodiol
• Scientific title: A Clinical Trial for the Off Label Use of Ursodiol for the Prevention of Recurrent C. Difficile Colitis and Diarrhea
• Date of first enrolment: March 1, 2017
• Target sample size: 9
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02748616
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Norman Javitt, MD
• Affiliation: NYU Langone Health

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diarrhea

Intervention(s)

Drug: Ursodiol

Primary Outcome(s)

The percent of patients with return toward a normal fecal bile acid pattern. [Time Frame: 2 months]

Secondary ID(s)

15-01348

Source(s) of Monetary Support

Please refer to primary and secondary sponsors