Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
Status:
Withdrawn
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
Patients with confirmed C. difficile infection (CDI) who meet eligibility requirements will
be invited to participate. All study patients must receive treatment for CDI with
metronidazole or vancomycin. Enrolled patients will be randomized in a 1:1 ratio to receive
MIYA-BM Fines Granules [Clostridium butyricum MIYAIRI 588 Strain (CBM588)] or a placebo
orally twice a day for 42 days. Patients will be evaluated for safety and clinical outcomes
through Day 180. Occurrence of adverse events (AEs), diarrhea history, and concomitant
medications will be evaluated at scheduled study visits and telephone contacts.