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

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Osel, Inc.
ClinicalTrials.gov Identifier:
NCT01077245
First received: February 25, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Clostridium Difficile Infection
Drug: MIYA-BM Fine Granules (CBM588)
Drug: Placebo Fine Granules (without CBM588)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Osel, Inc.:

Primary Outcome Measures:
  • Safety of MIYA-BM [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: February 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIYA-BM
MIYA-BM Fine Granules (CBM588)
Drug: MIYA-BM Fine Granules (CBM588)
MIYA-BM Fine Granules (CBM588)
Placebo Comparator: Placebo
Placebo Fine Granules (without CBM588)
Drug: Placebo Fine Granules (without CBM588)
Placebo Fine Granules (without CBM588)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077245

Sponsors and Collaborators
Osel, Inc.
Investigators
Principal Investigator: Lynne V. McFarland, Ph.D. VA Puget Sound Healthcare System
  More Information

No publications provided

Responsible Party: Osel, Inc.
ClinicalTrials.gov Identifier: NCT01077245     History of Changes
Other Study ID Numbers: CB-001
Study First Received: February 25, 2010
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Osel, Inc.:
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

Additional relevant MeSH terms:
Anti-Infective Agents
Gastrointestinal Agents
Physiological Effects of Drugs
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014