At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 89 enrolled

Drug / intervention

SER-109 +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02437487

NCT02437487Phase 2Completed

Compare CT.gov

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

Seres Therapeutics, Inc.·interventional·Posted May 7, 2015·Updated Jul 26, 2018

In Brief

A Phase 2 clinical trial evaluating SER-109 and Placebo for Clostridium Difficile. Completed, enrolled 89 participants across 30 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsClostridium Difficile

CountriesUnited States

CollaboratorsSyneos Health

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartMay 2015

First PostedMay 2015

Primary CompletionJul 2016

Study CompletionOct 2016

TodayJul 2026

First PostedMay 7, 2015

Enrollment StartMay 1, 2015

Primary CompletionJul 1, 2016

Study CompletionOct 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 11.2 years ago

Interventions

SER-109drug

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

Placebodrug

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.