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

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).

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Drug: SER-262; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Athens, Alabama, United States, 35749
      • North Alabama Research Center, LLC
  • California
    • Fountain Valley, California, United States, 92708
      • Lalla-Reddy Medical Corporation
    • La Mesa, California, United States, 91942
      • eStudySite
  • Florida
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic, Inc.
    • Orlando, Florida, United States, 32810
      • Omega Research Consultants
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Health System Research Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury St. Medical Group
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington Davis
    • Lima, Ohio, United States, 45801
      • Regional Infectious Diseases & Infusion Center
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Research Institute
  • Utah
    • Bountiful, Utah, United States, 84010
      • Dr. Hansen Internal Medicine
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Infectious Disease Associates of Central Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	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.
EXPERIMENTAL: SER-262; 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]	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.; Other Names: Cultivated Eubacterial Spore Suspension, Encapsulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings	Up to 24 weeks after treatment
Relative risk of recurrence based on the proportion of subjects experiencing CDI recurrence in each SER-262 cohort compared to placebo up to 8 weeks after treatment	Up to 8 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to recurrence of CDI	Up to 24 weeks after treatment
Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment	Up to 4, 12, and 24 weeks after treatment

Collaborators and Investigators

• Sponsor: Seres Therapeutics, Inc.
• Collaborators: Pharm-Olam International
• Investigators: Study Director: Michele Trucksis, Phd, MD, Seres Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (ESTIMATE): July 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Clostridium difficile; CDI; C Diff
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Clostridium Infections
• Other Study ID Numbers: SER-262-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO