The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
89
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
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.
Number of Subjects With CDI Recurrence
Time frame: 8 weeks after treatment.
Time to Recurrence of CDI
Kaplan-Meier estimate of median number of days to recurrence
Time frame: Recurrence of CDI up to 24 weeks after treatment.
Number of Subjects With CDI Recurrence
Time frame: 4 Weeks
Number of Subjects With CDI Recurrence
Time frame: 12 Weeks
Number of Subjects With CDI Recurrence
Time frame: 24 Weeks
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