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SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of SER-262 in Adults With Primary Clostridium Difficile Infection (CDI) to Prevent Recurrence

NCT02830542•Seres Therapeutics, Inc.

View on ClinicalTrials.gov

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).

Detailed Description

SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
•2. Male or female subjects ≥ 18 years.
•3. A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment

Exclusion Criteria

•1. Females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
•2. Known or suspected toxic megacolon and/or known small bowel ileus.
•3. Active irritable bowel syndrome with diarrhea within the previous 12 months.
•4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery.
•5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months.
•6. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
•7. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 may be enrolled.
•8. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
•9. Absolute neutrophil count \< 500 cells/mm3

Locations (22)

North Alabama Research Center, LLC

Athens, Alabama, United States

Lalla-Reddy Medical Corporation

Fountain Valley, California, United States

eStudySite

La Mesa, California, United States

San Marcus Research Clinic, Inc.

Miami, Florida, United States

Omega Research Consultants

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Snake River Research

Idaho Falls, Idaho, United States

Anne Arundel Health System Research Institute

Annapolis, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

May 1, 2018

Completion Date

August 1, 2018

Last Updated

February 6, 2023

Enrollment

ACTUAL participants

Conditions

Clostridium Difficile Infection

Interventions

SER-262

DRUG

Placebo

DRUG

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452

Clostridium DifficileClostridium Difficile Infections+8 more

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RECRUITINGNA

Safety and Efficacy of Fecal Microbiota Transplantation

NCT04014413

Crohn DiseaseUlcerative Colitis+25 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Safety and Efficacy of Fecal Microbiota Transplantation

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Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection

A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program