SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
NCT ID: NCT02437487
Last Updated: 2018-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2015-05-31
2016-10-31
Brief Summary
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Detailed Description
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Those patients who experience a recurrence of CDI up to 8 weeks after SER 109 or placebo treatment will be offered an opportunity to enroll in an open label SER 109 extension study (Study SERES 005).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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SER-109
SER 109 (1 × 108 SporQs)
SER-109
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
Placebo
Placebo
Placebo
Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
Interventions
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SER-109
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
Placebo
Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female patients ≥ 18 years.
3. ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode with documentation of ≥ 2 episodes.
Exclusion Criteria
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 24 months.
6. Admitted to or expected to be admitted to an acute care facility or intensive care unit for medical reasons (not just boarding). Patients discharged from an acute care facility before Day 1 or residing in nursing homes or rehabilitation facilities may be enrolled.
7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Seres Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michele Trucksis, Phd, MD
Role: STUDY_DIRECTOR
Seres Therapeutics
Locations
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North County Gastroenterology
Oceanside, California, United States
University Of California Davis
Sacramento, California, United States
Ventura Clinical Trials
Ventura, California, United States
ZASA Clinical Research
Atlantis, Florida, United States
Omega Research Consultants LLC
DeBary, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Emory University
Atlanta, Georgia, United States
Idaho Falls Infection Diseases
Idaho Falls, Idaho, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Anne Arundel Health System Research Institute
Annapolis, Maryland, United States
Johns Hopkins Bayview Medical
Baltimore, Maryland, United States
Metropolitan Gastroenterolgy Group Pc
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Med Cntr
Boston, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic
Chatfield, Minnesota, United States
Sundance Clinical Research
St Louis, Missouri, United States
Mercury Street Medical Group
Butte, Montana, United States
Englewood Hospital and Medical Center
Englewood Cliffs, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Remington-Davis, Inc.
Columbus, Ohio, United States
Regional Infectious Diseases-Infusion Center Inc
Lima, Ohio, United States
Drexel University/Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Brown Alpert Medical School
Providence, Rhode Island, United States
University of Texas School of Public Health
Houston, Texas, United States
Medical Associates of Central Virginia
Lynchburg, Virginia, United States
Countries
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References
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McGovern BH, Ford CB, Henn MR, Pardi DS, Khanna S, Hohmann EL, O'Brien EJ, Desjardins CA, Bernardo P, Wortman JR, Lombardo MJ, Litcofsky KD, Winkler JA, McChalicher CWJ, Li SS, Tomlinson AD, Nandakumar M, Cook DN, Pomerantz RJ, Aunins JG, Trucksis M. SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial. Clin Infect Dis. 2021 Jun 15;72(12):2132-2140. doi: 10.1093/cid/ciaa387.
Other Identifiers
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SERES-004
Identifier Type: -
Identifier Source: org_study_id
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