Status:
COMPLETED
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Lead Sponsor:
Rebiotix Inc.
Conditions:
Enterocolitis Clostridium Difficile Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) eff...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02299570
Start Date
December 1 2014
End Date
January 1 2018
Last Update
January 15 2021
Active Locations (21)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
4
Grand Teton Research Group
Idaho Falls, Idaho, United States, 83404