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Trial record 1 of 1 for:    NCT02589847
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Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

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: NCT02589847
Recruitment Status : Completed
First Posted : October 28, 2015
Results First Posted : May 11, 2020
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Rebiotix Inc.

Brief Summary:
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: RBX2660 Drug: Standard of Care Antibiotics Phase 2

Detailed Description:

This is a prospective, multicenter, open-label study assessing the efficacy and safety of RBX2660 as an adjunct to antibiotics for the treatment of recurrent CDI. Efficacy of RBX2660, measured by the recurrence-free rate of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment with RBX2660, will be evaluated by comparing the recurrence-free rate observed in the study population to the recurrence-free rate identified from antibiotic-treated historical controls.

Patients who have had either a) at least two recurrences after a primary episode (i.e., at least three episodes) and have completed at least two rounds of standard-of-care oral antibiotics or b) have had at least two episodes of severe CDI resulting in hospitalization may be eligible to participate in the study. Study visits are 1- and 8-weeks after treatment with additional follow-up assessments at 3,6,12, and 24 months post treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: RBX2660 Open-label
RBX2660 (microbiota suspension)
Biological: RBX2660
suspension of intestinal microbes

Historical control antibiotics
Retrospective Historical Control with standard of care
Drug: Standard of Care Antibiotics
Standard of Care Antibiotics
Other Name: Antibiotics




Primary Outcome Measures :
  1. Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks [ Time Frame: 8 weeks after treatment ]
    Participants were evaluated 8 weeks after study treatment to assess efficacy of RBX2660. Efficacy was assessed as the absence of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment.


Secondary Outcome Measures :
  1. Quality of Life (SF-36) [ Time Frame: Baseline ]
    The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.

  2. Quality of Life (SF-36) [ Time Frame: 8-Weeks ]
    The Short Form - 36 quality of life questionnaire (SF-36) is a tool used to identify changes to quality of life following study treatment. It consists of a series of 36 questions relating to Mental and Physical health, summarized by a Physical Component Score (PCS) and Mental Component Score (MCS), respectively. Several sub-scales exist for each of the larger components; PCS includes PF, RP, BP, and GH while, MCS includes VT, SF, RE, and MH [All abbreviations are defined in table]. All Sub-Scale and Component Scores were calculated using Quality Metric Health Outcomes Scoring Software v4.5. The range of all scores is normalized from 0 (worst) to 100 (best). The data is presented for mean scores at baseline and 8-weeks post-treatment.

  3. Number of Participants With Major Complications of rCDI From Baseline Through 24 Months [ Time Frame: 24 months ]
    Major complications of rCDI, defined as death, septic shock, toxic megacolon, colonic perforation, emergency colectomy, or ICU admission) were collected and reported as a safety-related endpoint.



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.


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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 old.
  • Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and 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 CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
  • Requires continuous antibiotic therapy for a condition other than CDI.
  • Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI < 6 months prior to study enrollment.
  • Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant.
  • Previous treatment with RBX2660.
  • Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  • Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  • History of chronic diarrhea.
  • History of celiac disease.
  • Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
  • Colostomy.
  • Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
  • Life expectancy of < 12 months.
  • Compromised immune system

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): NCT02589847


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85054
United States, Arkansas
North Little Rock, Arkansas, United States, 72117
United States, California
Sacramento, California, United States, 95817
United States, Florida
Bay Pines, Florida, United States, 33744
Coral Springs, Florida, United States, 33065
Gainesville, Florida, United States, 32610
Miami, Florida, United States, 33101
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Chicago, Illinois, United States, 60637
Maywood, Illinois, United States, 60153
United States, Indiana
Indianapolis, Indiana, United States, 46260
Lafayette, Indiana, United States, 47904
United States, Kentucky
Lexington, Kentucky, United States, 40506
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Rochester, Minnesota, United States, 55905
Saint Paul, Minnesota, United States, 55130
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New York
Bronx, New York, United States, 10468
Flushing, New York, United States, 11355
Rochester, New York, United States, 14618
Syracuse, New York, United States, 52325
United States, North Dakota
Fargo, North Dakota, United States, 58122
United States, Ohio
Lima, Ohio, United States, 45801
United States, Tennessee
Jackson, Tennessee, United States, 38305
United States, Texas
Houston, Texas, United States, 77025
United States, Virginia
Springfield, Virginia, United States, 22150
Virginia Beach, Virginia, United States, 23454
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z1M9
Canada, Ontario
Hamilton, Ontario, Canada, L8N4A6
Sponsors and Collaborators
Rebiotix Inc.
Investigators
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Study Chair: Arnab Ray, MD Ochsner Health System
  Study Documents (Full-Text)

Documents provided by Rebiotix Inc.:
Study Protocol  [PDF] January 20, 2016
Statistical Analysis Plan  [PDF] April 1, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rebiotix Inc.
ClinicalTrials.gov Identifier: NCT02589847    
Other Study ID Numbers: 2015-01
First Posted: October 28, 2015    Key Record Dates
Results First Posted: May 11, 2020
Last Update Posted: March 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:
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Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents