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

NCT02830542 | Completed Phase 1 DMC

• 1 other identifier: SER-262-001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 22

Brief 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

Keywords

Clostridium difficile; C Diff; CDI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

SER-262

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SER-262 DRUG

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.

Also known as: Cultivated Eubacterial Spore Suspension, Encapsulated

SER-262

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
• Male or female subjects ≥ 18 years.
• 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

You may not qualify if:

• Females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• Active irritable bowel syndrome with diarrhea within the previous 12 months.
• 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.
• 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.
• Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
• 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.
• Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
• Absolute neutrophil count \< 500 cells/mm3

Sponsors & Collaborators

• Seres Therapeutics, Inc.: lead
• Pharm-Olam International: collaborator

Study Sites (22)

North Alabama Research Center, LLC

Athens, Alabama, 35749, United States

Location

Lalla-Reddy Medical Corporation

Fountain Valley, California, 92708, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

San Marcus Research Clinic, Inc.

Miami, Florida, 33015, United States

Location

Omega Research Consultants

Orlando, Florida, 32810, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Snake River Research

Idaho Falls, Idaho, 83404, United States

Location

Anne Arundel Health System Research Institute

Annapolis, Maryland, 21401, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Mercury St. Medical Group

Butte, Montana, 59701, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Remington Davis

Columbus, Ohio, 43215, United States

Location

Regional Infectious Diseases & Infusion Center

Lima, Ohio, 45801, United States

Location

Baylor Scott & White Research Institute

Temple, Texas, 76508, United States

Location

Dr. Hansen Internal Medicine

Bountiful, Utah, 84010, United States

Location

Infectious Disease Associates of Central Virginia

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Michele Trucksis, PhD, MD

  Seres Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 13, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)