SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) (ECOSPOR)
|ClinicalTrials.gov Identifier: NCT02437487|
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : November 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile||Drug: SER-109 Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||October 2016|
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.
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437487
Show 30 Study Locations
|Study Director:||Michele Trucksis, Phd, MD||Seres Therapeutics|