Clostridium Difficile InfectionPhase 2NCT01077245
Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
A Phase 2 study testing MIYA-BM Fine Granules (CBM588) in people with Clostridium Difficile Infection, run by Osel, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- MIYA-BM Fine Granules (CBM588)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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
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.
Read the 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
- Being tested
- MIYA-BM Fine Granules (CBM588), Placebo Fine Granules (without CBM588)
- 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
- Medical subject headings
- Clostridium Infections, Gram-Positive Bacterial Infections, Bacterial Infections, Gastrointestinal Diseases, Colonic Diseases, Enterocolitis, Pseudomembranous, Intestinal Diseases, Enterocolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIYA-BM Fine Granules (CBM588)Drug
MIYA-BM Fine Granules (CBM588)
Placebo Fine Granules (without CBM588)Drug
Placebo Fine Granules (without CBM588)
| Study group | Role | What they receive |
|---|---|---|
| MIYA-BM | Experimental | MIYA-BM Fine Granules (CBM588) Receives: Drug: MIYA-BM Fine Granules (CBM588) |
| Placebo | Placebo comparator | Placebo Fine Granules (without CBM588) Receives: Drug: Placebo Fine Granules (without CBM588) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (1)
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynne V. McFarland, Ph.D., Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077245
- Sponsor's protocol ID
- CB-001
- Status last verified
- Nov 2013
- First submitted
- 25 Feb 2010
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01077245
- Acronym / sponsor ID
- CB-001
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile, Clostridium Infections, Gram-Positive Bacterial Infections, Bacterial Infections, Anti-Infective Agents, Clostridium butyricum, Metronidazole, Vancomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Osel, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIYA-BM | Experimental | Drug: MIYA-BM Fine Granules (CBM588)MIYA-BM Fine Granules (CBM588) |
| Placebo | Placebo comparator | Drug: Placebo Fine Granules (without CBM588)Placebo Fine Granules (without CBM588) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIYA-BM Fine Granules (CBM588)MIYA-BM Fine Granules (CBM588) | Drug | MIYA-BM |
| Placebo Fine Granules (without CBM588)Placebo Fine Granules (without CBM588) | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Efficacy of MIYA-BM
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne V. McFarland, Ph.D. principal investigator
VA Puget Sound Health Care System
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIYA-BM Fine Granules (CBM588) in people with Clostridium Difficile Infection, run by Osel, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of MIYA-BM (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.