Trial Outcomes & Findings for C. Difficile and Ursodiol (NCT NCT02748616)

Last Updated: 2022-01-11

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

2 months

Results posted on

2022-01-11

Participant milestones
Measure	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.
Overall Study STARTED	9
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	7

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	2
Overall Study Did Not Complete Ursodial Course	2

C. Difficile and Ursodiol

Baseline characteristics by cohort
Measure	Ursodiol n=9 Participants 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.
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

Timeframe: 2 months

Outcome measures
Measure	Ursodiol n=2 Participants 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.
Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern	100 percentage of participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

NYU Langone Health

Phone: 212-263-6588