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SER-262 for Clostridium Difficile Infection

Phase 1
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 8 weeks after treatment
Awards & highlights

Study Summary

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

Eligible Conditions
  • Clostridium Difficile Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings
Secondary outcome measures
Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment
Time to recurrence of CDI

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SER-262Experimental Treatment1 Intervention
SER-262 [Single dose: 10(4), 10(5), 10(6), 10(7) or 10(8) SCFUs; Multiple dose 10(6), 10(7), or 10(8) SCFUs]
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SER-262
2016
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Seres Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
884 Total Patients Enrolled
Pharm-Olam InternationalIndustry Sponsor
7 Previous Clinical Trials
2,215 Total Patients Enrolled
Michele Trucksis, PhD, MDStudy DirectorSeres Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
2016. "SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02830542.
~11 spots leftby Apr 2025
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