Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections

This study is a Phase 2 blinded, placebo-controlled, randomized clinical trial of an oral
probiotic product, MIYA-BM Fine Granules [Clostridium butyricum MIYAIRI 588 Strain
(CBM588)], in patients diagnosed with CDI and treated with metronidazole or vancomycin. Two
hundred patients who meet all eligibility criteria will be randomized in a 1:1 fashion to
receive either MIYA-BM (2g/dose) or placebo orally twice daily for 42 days. After
randomization, all patients will be followed for a total of 180 days (6 months) for safety
and recurrent CDI. If initially hospitalized, patients will be followed daily for diarrhea
history, collection of concomitant medications and AEs, and monitored for their response to
treatment. Patients will be followed through clinic visits and safety telephone calls. All
patients will be given a Diary Card to report AEs, diarrhea history, and concomitant
medications on a daily basis. If patients have signs or symptoms of CDI following resolution
of the initial episode, they will be instructed to return to the clinic as soon as possible
for evaluation of recurrent CDI. If a patient is diagnosed with recurrent CDI, they will
discontinue study treatment (MIYA-BM or placebo) and be treated and followed according to
the institution's standard of care for recurrent CDI.