Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
United States34 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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).
* Pla…
What they're measuring
1
Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660