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SER-109 for Clostridium Difficile (ECOSPOR Trial)

Phase 2
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 recurrence of cdi up to 24 weeks after treatment.

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.

Eligible Conditions
  • Clostridium Difficile

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recurrence of cdi up to 24 weeks after treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and recurrence of cdi up to 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.
Secondary study objectives
Time to Recurrence of CDI

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SER-109Experimental Treatment1 Intervention
SER 109 (1 × 108 SporQs)
Group II: PlaceboPlacebo Group1 Intervention
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?

Syneos HealthOTHER
175 Previous Clinical Trials
68,310 Total Patients Enrolled
Seres Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
876 Total Patients Enrolled
Michele Trucksis, Phd, MDStudy DirectorSeres Therapeutics
1 Previous Clinical Trials
~8 spots leftby Nov 2025
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