search
Back to results

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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SER-262
Placebo
Sponsored by
Seres Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring Clostridium difficile, C Diff, CDI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • North Alabama Research Center, LLC
  • Lalla-Reddy Medical Corporation
  • eStudySite
  • San Marcus Research Clinic, Inc.
  • Omega Research Consultants
  • Emory University Hospital
  • Clinical Research Atlanta
  • Snake River Research
  • Anne Arundel Health System Research Institute
  • Henry Ford Health System
  • Mayo Clinic
  • Sundance Clinical Research, LLC
  • Mercury St. Medical Group
  • Quality Clinical Research
  • Jersey Shore University Medical Center
  • Montefiore Medical Center
  • University of Rochester Medical Center
  • Remington Davis
  • Regional Infectious Diseases & Infusion Center
  • Baylor Scott & White Research Institute
  • Dr. Hansen Internal Medicine
  • Infectious Disease Associates of Central Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SER-262

Placebo

Arm Description

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]

Placebo

Outcomes

Primary Outcome Measures

Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings
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

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2016
Last Updated
February 2, 2023
Sponsor
Seres Therapeutics, Inc.
Collaborators
Pharm-Olam International
search

1. Study Identification

Unique Protocol Identification Number
NCT02830542
Brief Title
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seres Therapeutics, Inc.
Collaborators
Pharm-Olam International

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Clostridium difficile, C Diff, CDI

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SER-262
Arm Type
Experimental
Arm Description
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]
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SER-262
Other Intervention Name(s)
Cultivated Eubacterial Spore Suspension, Encapsulated
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings
Time Frame
Up to 24 weeks after treatment
Title
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
Time Frame
Up to 8 weeks after treatment
Secondary Outcome Measure Information:
Title
Time to recurrence of CDI
Time Frame
Up to 24 weeks after treatment
Title
Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment
Time Frame
Up to 4, 12, and 24 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Trucksis, PhD, MD
Organizational Affiliation
Seres Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35749
Country
United States
Facility Name
Lalla-Reddy Medical Corporation
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Snake River Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Anne Arundel Health System Research Institute
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercury St. Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Remington Davis
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Regional Infectious Diseases & Infusion Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Dr. Hansen Internal Medicine
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Infectious Disease Associates of Central Virginia
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs