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ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection

NCT03183128 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2023-04-27

Study results available
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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.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

SER-109

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

DRUG

Placebo

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%).

Sponsors & Collaborators

  • Seres Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa von Moltke, MD · Seres Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2020-07-03
Completion
2020-09-29
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs

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 NCT03183128 on ClinicalTrials.gov