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Trial record 4 of 6 for:    Rebiotix

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

This study is currently recruiting participants.
Verified August 2017 by Rebiotix Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03244644
First Posted: August 9, 2017
Last Update Posted: August 25, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rebiotix Inc.
  Purpose
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences 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 within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

Condition Intervention Phase
Clostridium Difficile Infection Drug: RBX2660 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection

Further study details as provided by Rebiotix Inc.:

Primary Outcome Measures:
  • Efficacy of RBX2660 compared to Placebo measured at 8 weeks [ Time Frame: 1, 4, and 8 weeks after completing the study treatment ]
    The absence of C. difficile diarrhea without the need for retreatment as assessed by subject interview and physical exam 1, 4, and 8 weeks after administration of the study treatment.


Secondary Outcome Measures:
  • Number of subjects with adverse events through 6 months [ Time Frame: Up to 6 months after completing the study treatment ]
    Documented adverse events will be categorized by frequency, severity, seriousness, and causality as assessed by subject interview and physical exam at 1-week, 4-week, and 8-week visits, and by subject phone interviews at 3 and 6 months from the last study treatment received.

  • Health Related Quality of Life (HRQOL) Assessment [ Time Frame: Up to 6 months after completing the study treatment ]
    Screening HRQOL scores will be compared to scores obtained at the 1-Week, 4-week, and 8-week assessment visits, and 3 and 6 month phone assessments


Estimated Enrollment: 270
Actual Study Start Date: July 31, 2017
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group A
Placebo is an enema of normal saline. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding
Drug: Placebo
Placebo is normal saline solution administered as an enema
Other Name: saline solution
Experimental: Group B
RBX2660 is an enema of a microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
Drug: RBX2660
RBX2660 is a microbiota suspension administered as an enema
Other Name: microbiota suspension

Detailed Description:
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI and (ii) safety via assessment of adverse events. Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the study enema and at months 3 and 6. Patients who have had at least two recurrences 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 within the last year may be eligible for the study. Study Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. ≥ 18 years old.
  2. Medical record documentation of recurrent CDI per the study definition, that includes 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 within the last year.
  3. A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
  4. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment.

[Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking this course of antibiotics]

Exclusion Criteria:

  1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
  2. Previous fecal transplant
  3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  5. Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
  6. An absolute neutrophil count of <1000 cells/µL during screening.
  7. Pregnant, breastfeeding, or intends to become pregnant during study participation.
  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): NCT03244644


Contacts
Contact: Paul Plumb 651-705-8778 studyinfo@Rebiotix.com
Contact: Beth Guthmueller 651-964-4477 studyinfo@Rebiotix.com

Locations
United States, Arkansas
North Little Rock Recruiting
North Little Rock, Arkansas, United States, 72117
United States, Idaho
Idaho Falls Recruiting
Idaho Falls, Idaho, United States, 83404
United States, New York
Rochester Recruiting
Rochester, New York, United States, 14618
United States, Oregon
Portland Recruiting
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Rebiotix Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT03244644     History of Changes
Other Study ID Numbers: 2017-01
First Submitted: August 2, 2017
First Posted: August 9, 2017
Last Update Posted: August 25, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rebiotix Inc.:
C Difficile Colitis
Clostridium Difficile
CDI
C.Difficile Diarrhea
Fecal Transplant
Fecal Microbiota Transplant
Microbiota Restoration Therapy
Diarrhea
FMT
Microbial Suspension

Additional relevant MeSH terms:
Infection
Communicable Diseases