- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01077245
Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
November 8, 2013 updated by: Osel, Inc.
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MIYA-BM
MIYA-BM Fine Granules (CBM588)
|
MIYA-BM Fine Granules (CBM588)
|
Placebo Comparator: Placebo
Placebo Fine Granules (without CBM588)
|
Placebo Fine Granules (without CBM588)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of MIYA-BM
Time Frame: 180 days
|
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.
|
180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of MIYA-BM
Time Frame: 60 days
|
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.
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lynne V. McFarland, Ph.D., VA Puget Sound Health Care System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
February 25, 2010
First Submitted That Met QC Criteria
February 25, 2010
First Posted (Estimate)
March 1, 2010
Study Record Updates
Last Update Posted (Estimate)
November 11, 2013
Last Update Submitted That Met QC Criteria
November 8, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
- Diarrhea
- Anti-Infective Agents
- Metronidazole
- Vancomycin
- Probiotics
- Bacterial Infections
- Gastroenteritis
- Gastrointestinal Diseases
- Digestive System Diseases
- Intestinal Diseases
- Clostridium difficile
- Physiological Effects of Drugs
- Colonic Diseases
- Pharmacologic Actions
- Therapeutic Uses
- Colitis
- Gastrointestinal Agents
- Enterocolitis
- Clostridium butyricum
- Gram-Positive Bacterial Infections
- Clostridium Infections
- Enterocolitis, Pseudomembranous
Additional Relevant MeSH Terms
Other Study ID Numbers
- CB-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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