Phase 2
N=133
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Enterocolitis Clostridium Difficile Recurrent
Bottom Line
View on ClinicalTrials.gov: NCT02299570 ↗Enrolled (actual)
133
Serious AEs
29.7%
Results posted
Jul 2018
Primary outcome: Primary: Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) — 25; 19; 20; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RBX2660 (microbiota suspension) (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rebiotix Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) |
25; 19; 20; 25 | — |
| SECONDARY Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) |
19; 25; 25; 19 | — |
| SECONDARY Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) |
25; 25; 20; 19 | — |
| SECONDARY SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) |
39.4; 39.4; 43.4; 44.3; 45.0; 46.4 | — |
| SECONDARY Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) |
91.1; 100; 73.3; 77.3; 66.7; 63.6 | — |
| SECONDARY Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) |
95.5; 100; 76.9; 77.3; 69.9; 63.6 | — |
| SECONDARY Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) |
91.1; 95.5; 73.3; 76.9; 66.7; 69.9 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02299570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.