NCT01077245

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

A Phase 2 Study to Evaluate the Safety and Potential Efficacy of Clostridium Butyricum MIYAIRI 588 Strain (MIYA-BM Fine Granules) for the Prevention of Recurrent Clostridium Difficile Infections

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Osel, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	MIYA-BM Fine Granules (CBM588)	MIYA-BM Fine Granules (CBM588)
DRUG	Placebo Fine Granules (without CBM588)	Placebo Fine Granules (without CBM588)

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2010-03-01
• Last updated: 2013-11-11