A total of 440 patients meeting enrollment criteria with a primary episode of C. Difficile Infection (CDI) will be enrolled across 3 sites. The total study time period for study procedures followed by clinical monitoring is anticipated to be about 24 months (biomarker assays and other analyses may be completed after the 24 month time period). All participants will receive oral antibiotics for CDI under the care of their physician. After consenting to participate in the study, participants will be randomized to receive either misoprostol (200 mcg po BID) or matching placebo for 14 days. Participants will be monitored for a total time-period of approximately 9 weeks with the goal of monitoring for recurrence of CDI during an 8-week follow-up period from the time that the course of antibiotic treatment is completed. Patients will have blood and stool samples (or rectal swabs if participants are unable to provide a stool sample) collected throughout the study to assess adherence, biomarkers, and to confirm recurrence of CDI (if necessary).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
6
Two 100mcg capsules twice per day
Two capsules twice per day
Washington University
St Louis, Missouri, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Number of Participants With Clinical Recurrence of Clostridium Difficile Infection (CDI).
Number of Participants with clinical recurrence of Clostridium Difficile Infection (CDI) in the 8 week follow-up period.
Time frame: 8 weeks
Number of Recurrences During the Follow-up Period
Number of recurrences during the follow-up period (for those who have a first recurrence during the follow-up time period)
Time frame: 8 weeks
Time to Resolution of Diarrhea
Time to resolution of diarrhea (TTROD; for those with recurrence)
Time frame: 8 weeks
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