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

Clostridium Difficile Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830542
• Other study ID #: SER-262-001
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2023
• Source: Seres Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Anne Arundel Health System Research Institute	Annapolis	Maryland
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Emory University Hospital	Atlanta	Georgia
United States	Dr. Hansen Internal Medicine	Bountiful	Utah
United States	Montefiore Medical Center	Bronx	New York
United States	Mercury St. Medical Group	Butte	Montana
United States	Remington Davis	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Lalla-Reddy Medical Corporation	Fountain Valley	California
United States	Snake River Research	Idaho Falls	Idaho
United States	eStudySite	La Mesa	California
United States	Regional Infectious Diseases & Infusion Center	Lima	Ohio
United States	Infectious Disease Associates of Central Virginia	Lynchburg	Virginia
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Quality Clinical Research	Omaha	Nebraska
United States	Omega Research Consultants	Orlando	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Baylor Scott & White Research Institute	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Seres Therapeutics, Inc.	Pharm-Olam International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to recurrence of CDI		Up to 24 weeks after treatment
Secondary	Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment		Up to 4, 12, and 24 weeks after treatment