Clinical trial NCT02589847: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Rebiotix Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: Quality of Life (SF-36)
timeFrame: Baseline
measure: Quality of Life (SF-36)
timeFrame: 8-Weeks
measure: Number of Participants With Major Complications of rCDI From Baseline Through 24 Months
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: North Little Rock
country: United States
state: Arkansas
city: Sacramento
country: United States
state: California
city: Bay Pines
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Detroit
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Bronx
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Fargo
country: United States
state: North Dakota
city: Lima
country: United States
state: Ohio
city: Jackson
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Springfield
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
Study officials:
affiliation: Ochsner Health System
name: Arnab Ray, MD
role: STUDY_CHAIR
References:
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.