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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02589847
First Posted: October 28, 2015
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rebiotix Inc.
  Purpose
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment with RBX2660 (microbiota suspension).

Condition Intervention Phase
Clostridium Difficile Infection Biological: RBX2660 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection

Further study details as provided by Rebiotix Inc.:

Primary Outcome Measures:
  • Assess Efficacy As The Absence Of CDI Diarrhea Without The Need For Retreatment With C. difficile Anti-infective Therapy Or Fecal Transplant Through 56 days After Completion Of Study Treatment With RBX2660. [ Time Frame: 8 weeks after treatment ]
    Subjects will return 8 weeks after study treatment to assess efficacy of RBX2660.


Secondary Outcome Measures:
  • Number Of Subjects With Adverse Events Through 12 months [ Time Frame: 12 months after treatment ]
    The number of subjects with adverse events will be calculated through 12 months after study treatment with RBX2660; event frequency, severity, and relatedness will be assessed.

  • Number of Subjects With Serious Adverse Events Through 24 Months [ Time Frame: 24 months after treatment ]
    The number of subjects with serious adverse events will be calculated through 24 months after study treatment; serious adverse event frequency, severity, and relatedness will be assessed through 24 months after completion treatment.


Enrollment: 150
Study Start Date: October 2015
Estimated Study Completion Date: January 2018
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: open label
RBX2660 (microbiota suspention)
Biological: RBX2660
suspension of intestinal microbes

Detailed Description:
This is a prospective, multicenter, open-label study assessing the efficacy and safety of RBX2660 as an adjunct to antibiotics for the treatment of recurrent CDI. The primary assessments for this study are (i) to assess efficacy as the absence of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment with RBX2660 and (ii) safety via assessment of adverse events. Patients who have had either a) at least two recurrences after a primary episode (i.e., at least three episodes) and have completed at least two rounds of standard-of-care oral antibiotics or b) have had at least two episodes of severe CDI resulting in hospitalization may be eligible to participate in the study. Study visits are 1- and 8-weeks after treatment with additional follow-up assessments at 3,6,12, and 24 months post treatment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old.
  • Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
  • Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
  • A positive stool test for the presence of C. difficile within 60 days prior to enrollment

Exclusion Criteria:

  • A known history of continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
  • Requires continuous antibiotic therapy for a condition other than CDI.
  • Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI < 6 months prior to study enrollment.
  • Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant.
  • Previous treatment with RBX2660.
  • Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  • Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  • History of chronic diarrhea.
  • History of celiac disease.
  • Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
  • Colostomy.
  • Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589847


  Show 30 Study Locations
Sponsors and Collaborators
Rebiotix Inc.
Investigators
Study Chair: Arnab Ray, MD Ochsner Health System
  More Information

Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT02589847     History of Changes
Other Study ID Numbers: 2015-01
First Submitted: October 26, 2015
First Posted: October 28, 2015
Last Update Posted: March 27, 2017
Last Verified: October 2016

Keywords provided by Rebiotix Inc.:
Fecal transplant
Fecal Microbiota transplant
fecal bacteriotherapy
Clostridium difficile
C diff
CDI
CDAD
diarrhea
FMT
microbiota restoration therapy
microbiota suspension
C diff diarrhea

Additional relevant MeSH terms:
Infection
Communicable Diseases