Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
1 other identifier
interventional
272
2 countries
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2015
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
May 11, 2020
CompletedMarch 26, 2021
February 1, 2021
1.7 years
October 26, 2015
April 28, 2020
March 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks after treatment
Secondary Outcomes (3)
Quality of Life (SF-36)
Baseline
Quality of Life (SF-36)
8-Weeks
Number of Participants With Major Complications of rCDI From Baseline Through 24 Months
24 months
Study Arms (2)
RBX2660 Open-label
EXPERIMENTALRBX2660 (microbiota suspension)
Historical control antibiotics
OTHERRetrospective Historical Control with standard of care
Interventions
Standard of Care Antibiotics
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rebiotix Inc.lead
Study Sites (30)
Unknown Facility
Phoenix, Arizona, 85054, United States
Unknown Facility
North Little Rock, Arkansas, 72117, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Bay Pines, Florida, 33744, United States
Unknown Facility
Coral Springs, Florida, 33065, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Miami, Florida, 33101, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Maywood, Illinois, 60153, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Lafayette, Indiana, 47904, United States
Unknown Facility
Lexington, Kentucky, 40506, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Saint Paul, Minnesota, 55130, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Flushing, New York, 11355, United States
Unknown Facility
Rochester, New York, 14618, United States
Unknown Facility
Syracuse, New York, 52325, United States
Unknown Facility
The Bronx, New York, 10468, United States
Unknown Facility
Fargo, North Dakota, 58122, United States
Unknown Facility
Lima, Ohio, 45801, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
Houston, Texas, 77025, United States
Unknown Facility
Springfield, Virginia, 22150, United States
Unknown Facility
Virginia Beach, Virginia, 23454, United States
Unknown Facility
Vancouver, British Columbia, V5Z1M9, Canada
Unknown Facility
Hamilton, Ontario, L8N4A6, Canada
Related Publications (3)
Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Therap Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.
PMID: 41245385DERIVEDReveles KR, Gonzales-Luna AJ, Golan Y, Alonso CD, Guthmueller B, Tan X, Bidell MR, Pokhilko V, Crawford CV, Skinner AM. Efficacy of Fecal Microbiota, Live-jslm (REBYOTA(R)), Among Patients Exposed to Non-Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Study. Open Forum Infect Dis. 2024 Jun 17;11(7):ofae341. doi: 10.1093/ofid/ofae341. eCollection 2024 Jul.
PMID: 39006315DERIVEDOrenstein 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.
PMID: 35279084DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development
- Organization
- Rebiotix, Inc.
Study Officials
- STUDY CHAIR
Arnab Ray, MD
Ochsner Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2015
First Posted
October 28, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2017
Study Completion
March 1, 2019
Last Updated
March 26, 2021
Results First Posted
May 11, 2020
Record last verified: 2021-02