ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection

April 6, 2023 updated by: Seres Therapeutics, Inc.

ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI)

Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study SERES-012.

Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cohort 1 is an open-label extension of study SERES-012. Subjects who had a CDI recurrence in study SERES-012 within 8 weeks of receipt of study drug, have responded to a course of standard of care (SOC) antibiotic treatment, will receive an oral dose of SER-109. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days.

Approximately 30 eligible subjects with recurrent CDI disease from study SERES-012 are expected to enroll. Screening for this study will begin at the Recurrence Visit of Study SERES-012.

Cohort 2 is an open-label program for subjects who were not part of SERES-012. Subjects 18 years of age or older who had one or more CDI recurrence and have responded to a course of antibiotic treatment will receive an oral dose of SER-109. The CDI recurrence must be confirmed by a positive C. difficile stool toxin or polymerase chain reaction (PCR) assay to confirm eligibility. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days.

Approximately 200 eligible subjects with recurrent CDI disease are expected to enroll.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
263

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • (Investigator site)
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • (Investigator site)
      • Victoria, British Columbia, Canada, V8R 1J8
        • (Investigator site)
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
        • (Investigator site)
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • (Investigator site)
      • North Bay, Ontario, Canada, P1B 2H3
        • (Investigator site)
      • Scarborough, Ontario, Canada, M1P 2T7
        • (Investigator site)
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7Y8
        • (Investigator site)
      • Québec, Quebec, Canada, G2J 0C4
        • (Investigator site)
      • Sainte-Foy, Quebec, Canada, G1W 4R4
        • (Investigator site)
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • (Investigator site)
    • Arizona
      • Sun City West, Arizona, United States, 85375
        • (Investigator site)
    • California
      • Mather, California, United States, 95655
        • (Investigator site)
      • Mountain View, California, United States, 94040
        • (Investigator site)
      • Murrieta, California, United States, 92563
        • (Investigator site)
      • Northridge, California, United States, 91324
        • (Investigator site)
      • Sacramento, California, United States, 95817
        • (Investigator site)
      • San Bernardino, California, United States, 92408
        • (Investigator site)
      • San Diego, California, United States, 92123
        • (Investigator site)
      • San Dimas, California, United States, 91773
        • (Investigator site)
      • Simi Valley, California, United States, 93065
        • (Investigator site)
      • Thousand Oaks, California, United States, 91360
        • (Investigator site)
    • Florida
      • Clearwater, Florida, United States, 33756
        • (Investigator site)
      • Clearwater, Florida, United States, 33761
        • (Investigator site)
      • DeLand, Florida, United States, 32720
        • (Investigator site)
      • Hialeah, Florida, United States, 33016
        • (Investigator site)
      • Homestead, Florida, United States, 33032
        • (Investigator site)
      • Jacksonville, Florida, United States, 32256
        • (Investigator site)
      • Miami, Florida, United States, 33125
        • (Investigator site)
      • Miami, Florida, United States, 33126
        • (Investigator site)
      • Miami, Florida, United States, 33144
        • (Investigator site)
      • Miami, Florida, United States, 33155
        • (Investigator site)
      • Miami, Florida, United States, 33165
        • (Investigator site)
      • Miami, Florida, United States, 33175
        • (Investigator site)
      • Miami Lakes, Florida, United States, 33014
        • (Investigator site)
      • Naples, Florida, United States, 34102
        • (Investigator site)
      • Orlando, Florida, United States, 32819
        • (Investigator site)
      • Pembroke Pines, Florida, United States, 33024
        • (Investigator site)
      • Pembroke Pines, Florida, United States, 33026
        • (Investigator site)
      • Port Orange, Florida, United States, 32127
        • (Investigator site)
    • Georgia
      • Athens, Georgia, United States, 30607
        • (Investigator site)
      • Atlanta, Georgia, United States, 30322
        • (Investigator site)
      • Decatur, Georgia, United States, 30033
        • (Investigator site)
      • Marietta, Georgia, United States, 30060
        • (Investigator site)
      • Morrow, Georgia, United States, 30260
        • (Investigator site)
    • Idaho
      • Boise, Idaho, United States, 83706
        • (Investigator site)
      • Idaho Falls, Idaho, United States, 83404
        • (Investigator site)
    • Illinois
      • Chicago, Illinois, United States, 60637
        • (Investigator site)
      • Oak Lawn, Illinois, United States, 60453
        • (Investigator site)
      • Springfield, Illinois, United States, 62703
        • (Investigator site)
    • Indiana
      • Evansville, Indiana, United States, 47714
        • (Investigator site)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • (Investigator site)
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • (Investigator site)
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • (Investigator site)
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • (Investigator site)
      • Chevy Chase, Maryland, United States, 20815
        • (Investigator site)
      • Glen Burnie, Maryland, United States, 21061
        • (Investigator site)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • (Investigator site)
      • Framingham, Massachusetts, United States, 01702
        • (Investigator site)
      • North Dartmouth, Massachusetts, United States, 02747
        • (Investigator site)
      • Weymouth, Massachusetts, United States, 02190
        • (Investigator site)
      • Worcester, Massachusetts, United States, 01655
        • (Investigator site)
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • (Investigator site)
      • Detroit, Michigan, United States, 48202
        • (Investigator site)
      • Flint, Michigan, United States, 48504
        • (Investigator site)
      • Royal Oak, Michigan, United States, 48073
        • (Investigator site)
      • Wyoming, Michigan, United States, 49519
        • (Investigator site)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • (Investigator site)
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • (Investigator site)
    • Montana
      • Butte, Montana, United States, 59701
        • (Investigator site)
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • (Investigator site)
      • Neptune, New Jersey, United States, 07754
        • (Investigator site)
    • New York
      • Buffalo, New York, United States, 14215
        • (Investigator site)
      • New York, New York, United States, 10279
        • (Investigator site)
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • (Investigator site)
      • Greenville, North Carolina, United States, 27834
        • (Investigator site)
      • Jacksonville, North Carolina, United States, 28546
        • (Investigator site)
      • Kinston, North Carolina, United States, 28501
        • (Investigator site)
    • Ohio
      • Akron, Ohio, United States, 44304
        • (Investigator site)
      • Centerville, Ohio, United States, 45459
        • (Investigator site)
      • Cincinnati, Ohio, United States, 45219
        • (Investigator site)
      • Cleveland, Ohio, United States, 44195
        • (Investigator site)
      • Mentor, Ohio, United States, 44060
        • (Investigator site)
      • Toledo, Ohio, United States, 43617
        • (Investigator site)
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • (Investigator site)
      • Harrisburg, Pennsylvania, United States, 17110
        • (Investigator site)
      • Pittsburgh, Pennsylvania, United States, 15213
        • (Investigator site)
      • Sayre, Pennsylvania, United States, 18840
        • (Investigator site)
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • (Investigator site)
    • Tennessee
      • Union City, Tennessee, United States, 38261
        • (Investigator site)
    • Texas
      • Cypress, Texas, United States, 77429
        • (Investigator site)
      • Garland, Texas, United States, 75044
        • (Investigator site)
      • Houston, Texas, United States, 77024
        • (Investigator site)
      • Houston, Texas, United States, 77025
        • (Investigator site)
      • Houston, Texas, United States, 77057
        • (Investigator site)
      • Houston, Texas, United States, 77084
        • (Investigator site)
      • McKinney, Texas, United States, 75071
        • (Investigator site)
      • Pasadena, Texas, United States, 77505
        • (Investigator site)
      • San Antonio, Texas, United States, 78229
        • (Investigator site)
      • Southlake, Texas, United States, 76092
        • (Investigator site)
      • Spring, Texas, United States, 77379
        • (Investigator site)
    • Utah
      • Ogden, Utah, United States, 84403
        • (Investigator site)
      • Riverton, Utah, United States, 84065
        • (Investigator site)
      • Salt Lake City, Utah, United States, 84114
        • (Investigator site)
    • Washington
      • Spokane, Washington, United States, 99202
        • (Investigator site)
      • Tacoma, Washington, United States, 98405
        • (Investigator site)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • (Investigator site)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Cohort 1 Main Inclusion Criteria:

  1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of a treatment regimen of SER-109 or placebo
  2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally authorized representative, must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
  3. The CDI recurrence in Study SERES-012 must have met the protocol definition of ≥ 3 unformed stools per day over 2 consecutive days, a positive C. difficile stool toxin assay, and the requirement of CDI SOC antibiotic therapy, and an adequate clinical response following antibiotic therapy (<3 unformed stools in 24 hours for 2 or more consecutive days).

Cohort 1 Main Exclusion Criteria:

  1. Female subjects 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. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
  4. Absolute neutrophil count of <500 cells/mm^3.
  5. Major gastrointestinal surgery (e.g. 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 (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
  6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
  7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
  8. Any history of fecal microbiota transplantation (FMT) in the past 3 months.

Cohort 2 Main Inclusion Criteria:

  1. Subjects 18 years of age or older who had one or more CDI recurrence (as confirmed by a C. difficile stool toxin or PCR test) and have responded to a course of antibiotic treatment.
  2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally authorized representative, must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.

Cohort 2 Main Exclusion Criteria:

(all Cohort 1 exclusion criteria [#1-8 above] plus the below addition criterion)

9. Previously enrolled in a Seres Therapeutics clinical study. An exception is made for subjects who screened in SERES-012 who did not receive SER-109 and did not previously roll-over to SERES-013.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SER-109
Received oral dose of SER-109
Biological: SER-109
SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores
Other Names:
  • Firmicutes spores

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cohort 1: Recurrence of CDI and Sustained Clinical Response
Time Frame: Up to Week 8
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Up to Week 8
Cohort 2: Recurrence of CDI and Sustained Clinical Response
Time Frame: Up to Weeks 8 and 12
Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.
Up to Weeks 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seres Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elaine Wang, MD, Seres Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SERES-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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