Back to results

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

Primary Purpose

Clostridium Difficile Infection

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MIYA-BM Fine Granules (CBM588)

Placebo Fine Granules (without CBM588)

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Clostridium difficile, Clostridium Infections, Gram-Positive Bacterial Infections, Bacterial Infections, Anti-Infective Agents, Clostridium butyricum, Metronidazole, Vancomycin, Gastrointestinal Diseases, Physiological Effects of Drugs, Colonic Diseases, Enterocolitis, Pseudomembranous, Intestinal Diseases, Enterocolitis, Pharmacologic Actions, Digestive System Diseases, Therapeutic Uses, Gastroenteritis, Colitis, Diarrhea, Probiotics, Gastrointestinal Agents

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.)
Has presence of toxic megacolon or ileus
Has presence of colostomy, naso-gastric tube, or indwelling central line
Has history of abdominal surgery within the previous 3 months (from time of enrollment)
Has recent history of other investigational drug use within 30 days of enrollment visit
Has planned investigational drug use while participating in this study
Is known to have HIV infection or AIDS or other immunosuppressive disease
Has taken systemic immunosuppressive drugs within 60 days of enrollment
Is currently taking or is planning to use an oral probiotic, other than yogurt, during the study
Has a known allergy to any component of MIYA-BM Fine Granules or placebo
Is unavailable for follow-up visits
At enrollment, has any social or medical condition, or psychiatric illness that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MIYA-BM

Placebo

Arm Description

MIYA-BM Fine Granules (CBM588)

Placebo Fine Granules (without CBM588)

Outcomes

Primary Outcome Measures

Safety of MIYA-BM

Evaluation of the safety of MIYA-BM compared to placebo in patients with CDI who are treated with metronidazole or vancomycin by comparing the adverse events (AEs) and serious adverse events (SAEs) in the MIYA-BM and placebo groups, as well as observed and self-reported clinical signs and symptoms, physical findings, and laboratory measurements.

Secondary Outcome Measures

Efficacy of MIYA-BM

Evaluation of the potential efficacy of MIYA-BM compared to placebo in the prevention of recurrent CDI as determined by the proportion of subjects with recurrent CDI and time to recurrence of the first CDI after initiation of MIYA-BM or placebo treatment.

Full Information

NCT ID

NCT01077245

First Posted

February 25, 2010

Last Updated

November 8, 2013

Sponsor

Osel, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01077245

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of enrollment

Study Start Date

February 2010 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Osel, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile Infection

Keywords

Clostridium difficile, Clostridium Infections, Gram-Positive Bacterial Infections, Bacterial Infections, Anti-Infective Agents, Clostridium butyricum, Metronidazole, Vancomycin, Gastrointestinal Diseases, Physiological Effects of Drugs, Colonic Diseases, Enterocolitis, Pseudomembranous, Intestinal Diseases, Enterocolitis, Pharmacologic Actions, Digestive System Diseases, Therapeutic Uses, Gastroenteritis, Colitis, Diarrhea, Probiotics, Gastrointestinal Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MIYA-BM

Arm Type

Experimental

Arm Description

MIYA-BM Fine Granules (CBM588)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Fine Granules (without CBM588)

Intervention Type

Drug

Intervention Name(s)

MIYA-BM Fine Granules (CBM588)

Intervention Description

MIYA-BM Fine Granules (CBM588)

Intervention Type

Drug

Intervention Name(s)

Placebo Fine Granules (without CBM588)

Intervention Description

Placebo Fine Granules (without CBM588)

Primary Outcome Measure Information:

Title

Safety of MIYA-BM

Description

Time Frame

180 days

Secondary Outcome Measure Information:

Title

Efficacy of MIYA-BM

Description

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.) Has presence of toxic megacolon or ileus Has presence of colostomy, naso-gastric tube, or indwelling central line Has history of abdominal surgery within the previous 3 months (from time of enrollment) Has recent history of other investigational drug use within 30 days of enrollment visit Has planned investigational drug use while participating in this study Is known to have HIV infection or AIDS or other immunosuppressive disease Has taken systemic immunosuppressive drugs within 60 days of enrollment Is currently taking or is planning to use an oral probiotic, other than yogurt, during the study Has a known allergy to any component of MIYA-BM Fine Granules or placebo Is unavailable for follow-up visits At enrollment, has any social or medical condition, or psychiatric illness that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lynne V. McFarland, Ph.D.

Organizational Affiliation

VA Puget Sound Health Care System

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs