Suspended

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

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What is being tested

MIYA-BM Fine Granules (CBM588)

+ Placebo Fine Granules (without CBM588)

Drug
Who is being recruted

Bacterial Infections and Mycoses+14

+ Bacterial Infections

+ Clostridium Infections

From 18 to 80 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: February 2010
See protocol details

Summary

Principal SponsorOsel, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2010

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
NCT01077245
Principal SponsorOsel, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsClostridium InfectionsColitisColonic DiseasesDiarrheaDigestive System DiseasesEnterocolitisEnterocolitis, PseudomembranousGastroenteritisGastrointestinal DiseasesInfectionsIntestinal DiseasesSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsGram-Positive Bacterial Infections

Criteria

4 inclusion criteria required to participate
Adult of either gender, aged 18-80 years old inclusive
Meets the case definition of CDI - recent history of diarrhea with presence of C. difficile toxin or pseudomembranous colitis; and no other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
CDI treated with metronidazole or vancomycin
If female and of reproductive potential, subject must not be pregnant (negative pregnancy test at time of screening) or breast-feeding, and currently using a reliable method of birth control
15 exclusion criteria prevent from participating
Has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
Has a history of acute pancreatitis within the last 3 months
Has a history of chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis)
Is unable to complete a daily study diary (mental incapacity, head trauma, etc.)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
MIYA-BM Fine Granules (CBM588)

Group II

Placebo
Placebo Fine Granules (without CBM588)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers