At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults
In Brief
A Phase 3 clinical trial evaluating SER-109 and Placebo for Clostridium Difficile Infection. Completed, enrolled 182 participants across 56 sites in 2 countries.
Detailed Summary
Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.
Study Details
Timeline
Interventions
SER-109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors Other Names: Eubacterial Spores, Purified Suspension, Encapsulated
Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline(0.9%).