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

NCT01077245 | Withdrawn Phase 2 DMC

• 1 other identifier: CB-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  180 days

Secondary Outcomes (1)

• Efficacy of MIYA-BM

  60 days

Study Arms (2)

MIYA-BM

EXPERIMENTAL

MIYA-BM Fine Granules (CBM588)

Drug: MIYA-BM Fine Granules (CBM588)

Placebo

PLACEBO COMPARATOR

Placebo Fine Granules (without CBM588)

Drug: Placebo Fine Granules (without CBM588)

Interventions

MIYA-BM Fine Granules (CBM588) DRUG

MIYA-BM Fine Granules (CBM588)

MIYA-BM

Placebo Fine Granules (without CBM588) DRUG

Placebo Fine Granules (without CBM588)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osel, Inc.: lead

MeSH Terms

Conditions

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Gastrointestinal Diseases; Colonic Diseases; Enterocolitis, Pseudomembranous; Intestinal Diseases; Enterocolitis; Digestive System Diseases; Gastroenteritis; Colitis; Diarrhea

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lynne V. McFarland, Ph.D.

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 11, 2013

Record last verified: 2013-11