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SER-109 for Clostridium Difficile Infection (ECOSPORIII Trial)

Phase 3
Waitlist Available
Research Sponsored by Seres Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4, 12 and 24 weeks after treatment
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Clostridium Difficile Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4, 12 and 24 weeks after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4, 12 and 24 weeks after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence of CDI up to 8 Weeks
Secondary study objectives
Recurrence of CDI up to 4, 12 and 24 Weeks

Side effects data

From 2022 Phase 3 trial • 263 Patients • NCT03183141
34%
Diarrhea
14%
Flatulence
10%
Nausea
10%
Abdominal pain
3%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 2

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SER-109Experimental Treatment1 Intervention
Received oral dose of SER-109
Group II: PlaceboPlacebo Group1 Intervention
Received matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SER-109
2015
Completed Phase 3
~540

Find a Location

Who is running the clinical trial?

Seres Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
783 Total Patients Enrolled
Lisa von Moltke, MDStudy DirectorSeres Therapeutics, Inc.
1 Previous Clinical Trials
203 Total Patients Enrolled
~22 spots leftby Oct 2025
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