search
Back to results

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RBX2660
Standard of Care Antibiotics
Sponsored by
Rebiotix Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Clostridium difficile, C diff, CDI, CDAD, Fecal transplant, Fecal Microbiota transplant, diarrhea, FMT, microbiota restoration therapy, microbiota suspension, fecal bacteriotherapy, C diff diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

RBX2660 Open-label

Historical control antibiotics

Arm Description

RBX2660 (microbiota suspension)

Retrospective Historical Control with standard of care

Outcomes

Primary Outcome Measures

Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks
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

Quality of Life (SF-36)
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.
Quality of Life (SF-36)
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.
Number of Participants With Major Complications of rCDI From Baseline Through 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.

Full Information

First Posted
October 26, 2015
Last Updated
March 25, 2021
Sponsor
Rebiotix Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02589847
Brief Title
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Official Title
An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rebiotix Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Clostridium difficile, C diff, CDI, CDAD, Fecal transplant, Fecal Microbiota transplant, diarrhea, FMT, microbiota restoration therapy, microbiota suspension, fecal bacteriotherapy, C diff diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RBX2660 Open-label
Arm Type
Experimental
Arm Description
RBX2660 (microbiota suspension)
Arm Title
Historical control antibiotics
Arm Type
Other
Arm Description
Retrospective Historical Control with standard of care
Intervention Type
Biological
Intervention Name(s)
RBX2660
Intervention Description
suspension of intestinal microbes
Intervention Type
Drug
Intervention Name(s)
Standard of Care Antibiotics
Other Intervention Name(s)
Antibiotics
Intervention Description
Standard of Care Antibiotics
Primary Outcome Measure Information:
Title
Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks
Description
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.
Time Frame
8 weeks after treatment
Secondary Outcome Measure Information:
Title
Quality of Life (SF-36)
Description
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.
Time Frame
Baseline
Title
Quality of Life (SF-36)
Description
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.
Time Frame
8-Weeks
Title
Number of Participants With Major Complications of rCDI From Baseline Through 24 Months
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnab Ray, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Study Chair
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
52325
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
City
Springfield
State/Province
Virginia
ZIP/Postal Code
22150
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35279084
Citation
Orenstein R, Dubberke ER, Khanna S, Lee CH, Yoho D, Johnson S, Hecht G, DuPont HL, Gerding DN, Blount KF, Mische S, Harvey A. Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial. BMC Infect Dis. 2022 Mar 12;22(1):245. doi: 10.1186/s12879-022-07256-y.
Results Reference
derived

Learn more about this trial

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

We'll reach out to this number within 24 hrs