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Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)

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: NCT01925417
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : July 1, 2015
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Study Description
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Brief Summary:
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.

Condition or disease Intervention/treatment Phase
Recurrent Clostridium Difficile Infection Biological: RBX2660 (microbiota suspension) Phase 2

Detailed Description:
This is the first study of a microbiota suspension derived from intestinal microbes. The primary assessments for this open label, multi-center study are (i) occurrence of product-related adverse events and (ii) resolution of CDAD at 56 days after administration of RBX2660. Subjects will also be assessed for time to CDAD recurrence, quality of life changes, and number of hospitalizations and length of stay for recurrent CDAD. Study visits will be at 7, 30, and 60 days after RBX2660 administration with additional follow-up at 3 and 6 months post treatment. Patients who have had at least two recurrences of CDAD 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 CDAD resulting in hospitalization may be eligible for the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Clinical Trial Demonstrating the Safety of RBX2660 Microbiota Suspension for the Treatment of Recurrent Clostridium Difficile-associated Diarrhea (CDAD): the PUNCH CD Study
Study Start Date : August 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
Experimental: RBX2660 (microbiota suspension)
enema-based delivery of RBX2660
 Biological: RBX2660 (microbiota suspension)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 [ Time Frame: 56 days ]
    Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.


Secondary Outcome Measures :
  1. Long-term Safety [ Time Frame: 6 months ]
    The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.

  2. Absence of CDAD at 56 Days [ Time Frame: 56 days ]
    Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.

  3. Quality of Life (SF-36) [ Time Frame: 60 days ]

    Quality of Life (SF-36) will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.

    The scale is from 0-100, with higher scores meaning better outcomes.


  4. Post-treatment Hospitalization Data [ Time Frame: 6 months ]
    number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.


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

Inclusion Criteria:

  • ≥ 18 years
  • Medical record documentation of CDAD either: a) at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or b) have had at least two episodes of severe CDAD resulting in hospitalization.
  • Willing and able to have an enema(s).
  • Already taking or will start a course of oral antibiotics for CDAD symptoms for 10-14 days, including at least seven days of oral vancomycin.
  • Willing and able to complete the required subject diary.

Exclusion Criteria:

  • Continued (uncontrolled) CDAD after completing a 10-14 day course of oral antibiotics.
  • Requires antibiotic therapy for a condition other than CDAD.
  • 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.
  • History of cirrhosis of the liver or ascites.
  • Disease symptoms caused by a confirmed intestinal pathogen other than Clostridium difficile.
  • Has a colostomy.
  • Intraabdominal surgery within the last 60 days.
  • Evidence of active, severe colitis.
  • History of short gut syndrome or motility disorders.
  • Requires the regular use of medications that affect bowel motility (e.g., metoclopramide, narcotics, loperamide).
  • Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
  • Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system, e.g., HIV infection (any CD4 count); AIDS-defining diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy; or current or recent (< 90 days) treatment with immunosuppressant medications.
  • Taking steroids (≥ 20 mg a day) or is expected to be on steroids for more than 30 days after enrollment.
  • Neutropenia (white blood cell count <1000 cells/µL).
Contacts and Locations
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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): NCT01925417


Locations
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United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, Colorado
Denver Health and University of Colorado
Denver, Colorado, United States, 80204
United States, Florida
Borland-Groover Clinic
Jacksonville, Florida, United States, 32216
United States, Illinois
Edward Hines Jr VA Hospital (veterans only)
Chicago, Illinois, United States, 60141
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic - Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, North Dakota
Sanford Research/USD
Fargo, North Dakota, United States, 58122
Sponsors and Collaborators
Rebiotix Inc.
Investigators
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Study Chair: Dimitri Drekonja, MD Veteran Administration Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT01925417    
Other Study ID Numbers: 2013-001
First Posted: August 19, 2013    Key Record Dates
Results First Posted: July 1, 2015
Last Update Posted: November 13, 2019
Last Verified: September 2018
Keywords provided by Rebiotix Inc.:
Clostridium difficile
C diff
Microbiota Restoration Therapy
MRT
microbiota suspension
CDI
 CDAD
Fecal transplant
Fecal Microbiota Transplant
FMT
Diarrhea
Fecal bacteriotherapy
Additional relevant MeSH terms:
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Clostridium Infections
Recurrence
Diarrhea
Disease Attributes
Pathologic Processes
 Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections