Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

NCT ID: NCT02589847

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2019-03-31

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.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RBX2660 Open-label

RBX2660 (microbiota suspension)

Group Type: EXPERIMENTAL

RBX2660

Intervention Type: BIOLOGICAL

suspension of intestinal microbes

Historical control antibiotics

Retrospective Historical Control with standard of care

Group Type: OTHER

Standard of Care Antibiotics

Intervention Type: DRUG

Standard of Care Antibiotics

Interventions

RBX2660

suspension of intestinal microbes

Intervention Type: BIOLOGICAL

Standard of Care Antibiotics

Standard of Care Antibiotics

Intervention Type: DRUG

Other Intervention Names

Antibiotics

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rebiotix Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnab Ray, MD

Role: STUDY_CHAIR

Ochsner Health System

Locations

Phoenix, Arizona, United States

North Little Rock, Arkansas, United States

Sacramento, California, United States

Bay Pines, Florida, United States

Coral Springs, Florida, United States

Gainesville, Florida, United States

Miami, Florida, United States

Idaho Falls, Idaho, United States

Chicago, Illinois, United States

Maywood, Illinois, United States

Indianapolis, Indiana, United States

Lafayette, Indiana, United States

Lexington, Kentucky, United States

Detroit, Michigan, United States

Rochester, Minnesota, United States

Saint Paul, Minnesota, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Flushing, New York, United States

Rochester, New York, United States

Syracuse, New York, United States

The Bronx, New York, United States

Fargo, North Dakota, United States

Lima, Ohio, United States

Jackson, Tennessee, United States

Houston, Texas, United States

Springfield, Virginia, United States

Virginia Beach, Virginia, United States

Vancouver, British Columbia, Canada

Hamilton, Ontario, Canada

Countries

United States; Canada

References

Reveles 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.

Reference Type: DERIVED

PMID: 39006315 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35279084 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-01

Identifier Type: -

Identifier Source: org_study_id