Trial record 49 of 91 for:    gastroenterology | Recruiting | Exclude Unknown | United States

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Rebiotix Inc.
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.
ClinicalTrials.gov Identifier:
NCT02299570
First received: November 19, 2014
Last updated: August 14, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention Phase
Recurrent Clostridium Difficile Infection
Biological: RBX2660 (microbiota suspension)
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Rebiotix Inc.:

Primary Outcome Measures:
  • Efficacy of Active Treatment Compared to Placebo at Measured at 8 weeks Post-treatment [ Time Frame: 8 weeks after last assigned study treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Subjects with Adverse Events Through 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 117
Study Start Date: November 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Two enemas of RBX2660 administered 7 days apart
Biological: RBX2660 (microbiota suspension)
A suspension of intestinal microbes
Placebo Comparator: Group B
Two enemas of placebo administered 7 days apart
Other: Placebo
A suspension of saline and cryoprotectant
Active Comparator: Group C
1 enema of RBX2660 and 1 enema of placebo administered 7 days apart
Biological: RBX2660 (microbiota suspension)
A suspension of intestinal microbes
Other: Placebo
A suspension of saline and cryoprotectant

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02299570

Contacts
Contact: Paul Plumb 651-705-8778 pplumb@rebiotix.com
Contact: Beth Guthmueller 651-964-4477 bguthmueller@rebiotix.com

  Show 21 Study Locations
Sponsors and Collaborators
Rebiotix Inc.
Investigators
Study Chair: Teena Chopra, MD MPH Wayne State University
  More Information

Additional Information:
Publications:
Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT02299570     History of Changes
Other Study ID Numbers: 2014-01 
Study First Received: November 19, 2014
Last Updated: August 14, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on April 27, 2016