Phase
Condition
Gastroenteritis
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Vancomycin
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing to provide informed consent.
Willing to comply with all study procedures and be available for the duration of thestudy.
Documented diagnosis of at least one CDI within the last 180 days with treatmentcompleted.
Currently receiving systemic antibiotics for a non-CDI condition with anticipatedduration of no more than 2 weeks.
Females of childbearing potential must have a negative pregnancy test prior torandomization and agree to use adequate contraception prior to randomization, forthe duration of the study, and for 4 weeks following study completion.
Have received no more than 72 hours of non-CDI antibiotics.
Exclusion
Exclusion Criteria:
History of hypersensitivity or allergy to oral vancomycin.
Current use of oral vancomycin
Patients on concurrent treatment with metronidazole or tetracycline monotherapy forany indication
Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterialgastrointestinal infection cause by agents other than C. difficile (e.g. Salmonellasp.), toxic megacolon and/or known small bowel ileus.
Dysphagia (inability to swallow capsules) or unwilling to swallow capsules.
Major gastrointestinal surgery within 3 months of enrollment (does not includeappendectomy or cholecystectomy).
Any history of total colectomy or bariatric surgery.
Unable or unwilling to fulfill study requirements.
Expected life expectancy < 6 months.
Patients enrolled in another clinical trial with investigational drugs within 30days prior to randomization.
Women who are pregnant or breast-feeding.
Any patient deemed not suitable for study participation at the discretion of thestudy investigator.
Diarrhea (3 or more loose stools in a 24 hour period) at enrollment.
Study Design
Study Description
Connect with a study center
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Division of Gastroenterology & Hepatology, Mayo clinic
Rochester, Minnesota 55905
United StatesSite Not Available
University of Wisconsin-Madison
Madison, Wisconsin 53705
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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