Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Completed · Phase 2

Conditions studied: Clostridium Difficile Infection

In brief

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).

Key facts

Study ID

NCT02589847

Run by

Rebiotix Inc.

People needed

272

Starts

2015-10-01

Expected to finish

2019-03-01

Last updated by the study team

2021-03-26

Who can join

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

You may qualify if…

• ≥ 18 years old.
• Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and 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

You may not qualify if…

• A known history of continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
• Requires continuous antibiotic therapy for a condition other than CDI.
• Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI < 6 months prior to study enrollment.
• Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant.
• Previous treatment with RBX2660.
• Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
• Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
• History of chronic diarrhea.
• History of celiac disease.
• Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
• Colostomy.
• Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
• Life expectancy of < 12 months.
• Compromised immune system

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Sacramento, California, United States
• Study site — Bay Pines, Florida, United States
• Study site — Coral Springs, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lafayette, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Flushing, New York, United States
• Study site — Rochester, New York, United States
• Study site — Syracuse, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Fargo, North Dakota, United States
• Study site — Lima, Ohio, United States
• Study site — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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