Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

Completed · Phase 2

Conditions studied: Recurrent Clostridium Difficile Infection

In brief

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.

Key facts

Study ID

NCT01925417

Run by

Rebiotix Inc.

People needed

34

Starts

2013-08-01

Expected to finish

2014-07-01

Last updated by the study team

2019-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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).

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Denver Health and University of Colorado — Denver, Colorado, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Edward Hines Jr VA Hospital (veterans only) — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Detroit Medical Center — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic - Minnesota — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Sanford Research/USD — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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