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

NCT02437487 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2018-07-26

Study results available
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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.

Conditions

  • Clostridium Difficile

Interventions

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.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Seres Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michele Trucksis, Phd, MD · Seres Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02437487 on ClinicalTrials.gov