MedTrace Logo

SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

NCT02830542 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-02-06

No results posted yet for this 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).

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

SER-262

SER-262 is a rationally designed, multi-strain Ecobiotic® microbiome therapeutic produced synthetically by in vitro fermentation. It is a consortium of anaerobic, commensal bacteria in spore form, encapsulated for oral administration.

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.

Sponsors & Collaborators

  • Pharm-Olam International

    collaborator INDUSTRY

  • 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
2016-08-31
Primary Completion
2018-05-31
Completion
2018-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02830542 on ClinicalTrials.gov