SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) (ECOSPOR)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection|
- Relative risk of recurrence of CDI up to 8 weeks after treatment. [ Time Frame: 8 weeks after treatment. ]
- Time to recurrence of CDI [ Time Frame: Recurrence of CDI up to 4, 8, 12 and 24 weeks after treatment. ]
|Study Start Date:||May 2015|
|Study Completion Date:||October 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
SER 109 (1 × 108 SporQs)
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
Other Name: Purified Eubacterial Spores, Encapsulated
Placebo Comparator: Placebo
Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
ECOSPOR is a Phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (SER-109 or placebo). Patients who have diarrhea and a positive C. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on Day 1.
Those patients who experience a recurrence of CDI up to 8 weeks after SER 109 or placebo treatment will be offered an opportunity to enroll in an open label SER 109 extension study (Study SERES 005).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02437487
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|Study Director:||Michele Trucksis, Phd, MD||Seres Therapeutics|