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

NCT01077245 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-11-11

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

MIYA-BM Fine Granules (CBM588)

MIYA-BM Fine Granules (CBM588)

DRUG

Placebo Fine Granules (without CBM588)

Placebo Fine Granules (without CBM588)

Sponsors & Collaborators

  • Osel, Inc.

    lead INDUSTRY

Principal Investigators

  • Lynne V. McFarland, Ph.D. · VA Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-11-30
Completion
2013-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077245 on ClinicalTrials.gov