Overview

This trial is active, not recruiting.

Condition enterocolitis clostridium difficile recurrent
Treatments rbx2660 (microbiota suspension), placebo
Phase phase 2
Sponsor Rebiotix Inc.
Start date November 2014
End date November 2015
Trial size 117 participants
Trial identifier NCT02299570, 2014-01

Summary

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Two enemas of RBX2660 administered 7 days apart
rbx2660 (microbiota suspension)
A suspension of intestinal microbes
(Placebo Comparator)
Two enemas of placebo administered 7 days apart
placebo
A suspension of saline and cryoprotectant
(Active Comparator)
1 enema of RBX2660 and 1 enema of placebo administered 7 days apart
rbx2660 (microbiota suspension)
A suspension of intestinal microbes
placebo
A suspension of saline and cryoprotectant

Primary Outcomes

Measure
Efficacy of Active Treatment Compared to Placebo at Measured at 8 weeks Post-treatment
time frame: 8 weeks after last assigned study treatment

Secondary Outcomes

Measure
Number of Subjects with Adverse Events Through 12 Months
time frame: 12 months
Number of Subjects with Serious Adverse Events Through 24 Months
time frame: 24 months after last treatment with RBX2660

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - ≥ 18 years - Medical record documentation of recurrent CDI 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 C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment. - Requires antibiotic therapy for a condition other than recurrent CDI. - Previous fecal transplant prior to study enrollment. - History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis. - History of irritable bowel syndrome (IBS). - History of chronic diarrhea. - History of celiac disease. - Colostomy. - Planned surgery requiring perioperative antibiotics within 6 months of study enrollment. - Life expectancy of < 12 months. - Compromised immune system.

Additional Information

Official title A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Description This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Rebiotix Inc..