NCT02437487

SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)

ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Seres Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
DRUG	SER-109	SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
DRUG	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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-07-01
• Completion: 2016-10-01
• First posted: 2015-05-07
• Last updated: 2018-07-26
• Results posted: 2018-07-26

Locations

30 sites across 1 country: United States