WithdrawnPhase 2

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

Stopped: Lack of enrollment

0Started 2010-02

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, du…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of MIYA-BM

Timeframe: 180 days

Trial details

NCT IDNCT01077245

SponsorOsel, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Clostridium Difficile Infection trials