Phase 2
N=34
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
Recurrent Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT01925417 ↗Enrolled (actual)
34
Serious AEs
20.6%
Results posted
Jul 2015
Primary outcome: Primary: Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 — 10 number of reported SAEs through 56 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RBX2660 (microbiota suspension) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rebiotix Inc.
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 |
10 | — |
| SECONDARY Long-term Safety |
20 | — |
| SECONDARY Absence of CDAD at 56 Days |
27 | — |
| SECONDARY Quality of Life (SF-36) |
42.2; 47.7; 48.6; 51.3 | — |
| SECONDARY Post-treatment Hospitalization Data |
— | — |
Summary
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years
- Medical record documentation of CDAD either: a) at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or b) have had at least two episodes of severe CDAD resulting in hospitalization.
- Willing and able to have an enema(s).
- Already taking or will start a course of oral antibiotics for CDAD symptoms for 10-14 days, including at least seven days of oral vancomycin.
- Willing and able to complete the required subject diary.
Exclusion Criteria
- Continued (uncontrolled) CDAD after completing a 10-14 day course of oral antibiotics.
- Requires antibiotic therapy for a condition other than CDAD.
- 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.
- History of cirrhosis of the liver or ascites.
- Disease symptoms caused by a confirmed intestinal pathogen other than Clostridium difficile.
- Has a colostomy.
- Intraabdominal surgery within the last 60 days.
- Evidence of active, severe colitis.
- History of short gut syndrome or motility disorders.
- Requires the regular use of medications that affect bowel motility (e.g., metoclopramide, narcotics, loperamide).
- Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
- Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
- Life expectancy of < 12 months.
- Compromised immune system, e.g., HIV infection (any CD4 count); AIDS-defining diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy; or current or recent (< 90 days) treatment with immunosuppressant medications.
- Taking steroids (≥ 20 mg a day) or is expected to be on steroids for more than 30 days after enrollment.
- Neutropenia (white blood cell count <1000 cells/µL).
Data sourced from ClinicalTrials.gov (NCT01925417). 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.