ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
NCT ID: NCT03183141
Last Updated: 2023-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
263 participants
INTERVENTIONAL
2017-10-23
2022-04-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SER-109
Received oral dose of SER-109
SER-109
SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores
Interventions
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SER-109
SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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).
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.
Exclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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Seres Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Elaine Wang, MD
Role: STUDY_DIRECTOR
Seres Therapeutics, Inc.
Locations
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(Investigator site)
Dothan, Alabama, United States
(Investigator site)
Sun City West, Arizona, United States
(Investigator site)
Mather, California, United States
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Mountain View, California, United States
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Murrieta, California, United States
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Northridge, California, United States
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Sacramento, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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Simi Valley, California, United States
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Thousand Oaks, California, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Pembroke Pines, Florida, United States
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Port Orange, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Morrow, Georgia, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
(Investigator site)
Oak Lawn, Illinois, United States
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Springfield, Illinois, United States
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Evansville, Indiana, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Annapolis, Maryland, United States
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Chevy Chase, Maryland, United States
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Glen Burnie, Maryland, United States
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Boston, Massachusetts, United States
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Framingham, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Weymouth, Massachusetts, United States
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Worcester, Massachusetts, United States
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Chesterfield, Michigan, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Royal Oak, Michigan, United States
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Wyoming, Michigan, United States
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Rochester, Minnesota, United States
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Chesterfield, Missouri, United States
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Butte, Montana, United States
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Morristown, New Jersey, United States
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Neptune City, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Jacksonville, North Carolina, United States
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Kinston, North Carolina, United States
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Akron, Ohio, United States
(Investigator site)
Centerville, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Mentor, Ohio, United States
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Toledo, Ohio, United States
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Camp Hill, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Providence, Rhode Island, United States
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Union City, Tennessee, United States
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Cypress, Texas, United States
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Garland, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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Pasadena, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Spring, Texas, United States
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Ogden, Utah, United States
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Riverton, Utah, United States
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Salt Lake City, Utah, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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London, Ontario, Canada
(Investigator site)
North Bay, Ontario, Canada
(Investigator site)
Scarborough Village, Ontario, Canada
(Investigator site)
Chicoutimi, Quebec, Canada
(Investigator site)
Québec, Quebec, Canada
(Investigator site)
Sainte-Foy, Quebec, Canada
Countries
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References
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Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28.
Sims MD, Khanna S, Feuerstadt P, Louie TJ, Kelly CR, Huang ES, Hohmann EL, Wang EEL, Oneto C, Cohen SH, Berenson CS, Korman L, Lee C, Lashner B, Kraft CS, Ramesh M, Silverman M, Pardi DS, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L; ECOSPOR IV Investigators. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255758. doi: 10.1001/jamanetworkopen.2022.55758.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SERES-013
Identifier Type: -
Identifier Source: org_study_id
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