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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)

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.
 
ClinicalTrials.gov Identifier: NCT02299570
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : July 27, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2014
First Posted Date  ICMJE November 24, 2014
Results First Submitted Date  ICMJE July 2, 2018
Results First Posted Date  ICMJE July 27, 2018
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
Efficacy of Active Treatment Compared to Placebo at Measured at 8 Weeks Post-treatment [ Time Frame: 8 weeks after last assigned study treatment ]
The absence of C. difficile diarrhea without the need for retreatment at 56 days after administration of the last assigned study enema, will be compared between the number of subjects who receive two enemas of RBX2660 to the number of subjects who receive two enemas of placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • Number of Subjects With Adverse Events Through 12 Months [ Time Frame: 12 months ]
    The number of subjects in each treatment group with adverse events will be calculated through 12 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.
  • Number of Subjects With Serious Adverse Events Through 24 Months [ Time Frame: 24 months after last treatment with RBX2660 ]
    The number of subjects in each treatment group with serious adverse events will be calculated through 24 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Official Title  ICMJE A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Brief Summary This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Detailed Description This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Enterocolitis Clostridium Difficile Recurrent
Intervention  ICMJE
  • Biological: RBX2660 (microbiota suspension)
    A suspension of intestinal microbes
  • Other: Placebo
    A suspension of saline and cryoprotectant
Study Arms  ICMJE
  • Active Comparator: Group A
    Two enemas of RBX2660 (microbiota suspension) administered 7 days apart
    Intervention: Biological: RBX2660 (microbiota suspension)
  • Placebo Comparator: Group B
    Two enemas of placebo administered 7 days apart
    Intervention: Other: Placebo
  • Active Comparator: Group C
    1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart
    Interventions:
    • Biological: RBX2660 (microbiota suspension)
    • Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2018)
150
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
117
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥ 18 years
  • Medical record documentation of recurrent CDI 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 C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
  • Requires antibiotic therapy for a condition other than recurrent CDI.
  • Previous fecal transplant prior to study enrollment.
  • History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  • History of irritable bowel syndrome (IBS).
  • History of chronic diarrhea.
  • History of celiac disease.
  • Colostomy.
  • Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02299570
Other Study ID Numbers  ICMJE 2014-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebiotix Inc.
Study Sponsor  ICMJE Rebiotix Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Teena Chopra, MD MPH Wayne State University
PRS Account Rebiotix Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP