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History of Changes for Study: NCT01925417
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)
Latest version (submitted October 30, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 15, 2013 None (earliest Version on record)
2 August 26, 2013 Contacts/Locations, Conditions and Study Status
3 September 10, 2013 Contacts/Locations and Study Status
4 September 23, 2013 Contacts/Locations and Study Status
5 October 10, 2013 Contacts/Locations and Study Status
6 October 21, 2013 Contacts/Locations and Study Status
7 November 1, 2013 Contacts/Locations, Conditions and Study Status
8 November 11, 2013 Study Status and Contacts/Locations
9 January 9, 2014 Recruitment Status, Study Status and Contacts/Locations
10 August 12, 2014 Recruitment Status, Study Status and Study Design
11 June 30, 2015 Study Status, Outcome Measures, Results and Study Design
12 April 24, 2017 Study Status, Outcome Measures and Contacts/Locations
13 September 7, 2018 Outcome Measures, More Information, Study Status, Contacts/Locations and Arms and Interventions
14 October 30, 2019 Outcome Measures and Study Status
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Study NCT01925417
Submitted Date:  August 15, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2013-001
Brief Title: Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2013
Overall Status: Recruiting
Study Start: August 2013
Primary Completion: March 2014 [Anticipated]
Study Completion: July 2014 [Anticipated]
First Submitted: August 15, 2013
First Submitted that
Met QC Criteria:
August 15, 2013
First Posted: August 19, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 15, 2013
Last Update Posted: August 19, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Rebiotix Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Recurrent Clostridium Difficile Infection
Keywords: Clostridium difficile
C diff
CDI
CDAD
Fecal transplant
Fecal Microbiota Transplant
FMT
Diarrhea
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: RBX2660 (microbiota suspension) Biological: RBX2660 (microbiota suspension)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety
[ Time Frame: 56 days ]

Safety will be assessed by evaluating the incidence, severity, and relatedness of serious adverse events through 56 days after the last treatment with RBX2660.
Secondary Outcome Measures:
1. Long-term Safety
[ Time Frame: 6 months ]

Serious adverse events will be assessed through 6 months after the last treatment with RBX2660.
2. Efficacy
[ Time Frame: 56 days ]

Absence or presence of CDAD at Day 56 after receiving RBX2660. Subjects who reoccur before Day 56 may receive a second treatment with RBX2660 within 10 days of recurrence.
3. Quality of Life
[ Time Frame: 60 days ]

Quality of life 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.
4. Post-treatment Hospitalization Data
[ Time Frame: 6 months ]

Hospitalization cost, number of ICU days, and length of stay data will be collected for subjects who receive RBX2660 and who are subsequently hospitalized for recurrent CDAD treatment.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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).
Open or close this module Contacts/Locations
Central Contact Person: Mary Kay Sobcinski, RN MHA
Telephone: 651 964 4488
Email: mksobcinski@rebiotix.com
Central Contact Backup: Beth Guthmueller, CCRC
Telephone: 651 964 4477
Email: bguthmueller@rebiotix.com
Locations: United States, Maryland
Chevy Chase Clinical Research
[Recruiting]
Chevy Chase, Maryland, United States, 20815
Contact:Contact: Robert Hardi, MD CPI 301-652-5520 robert.hardi@metrogastro.com
Contact:Contact: Kathy Tracey, LPN CRC 301 652 5520 kathy.tracey@capitaldigestivecare.com
Contact:Principal Investigator: Robert Hardi, MD CPI
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16. PubMed 23323867
Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632. Review. PubMed 22002980
Rohlke F, Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Therap Adv Gastroenterol. 2012 Nov;5(6):403-20. doi: 10.1177/1756283X12453637. PubMed 23152734
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