SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
NCT ID: NCT02830542
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
96 participants
INTERVENTIONAL
2016-08-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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SER-262
SER-262 \[Single dose: 10(4), 10(5), 10(6), 10(7) or 10(8) SCFUs; Multiple dose 10(6), 10(7), or 10(8) SCFUs\]
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Pharm-Olam International
INDUSTRY
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 Alabama Research Center, LLC
Athens, Alabama, United States
Lalla-Reddy Medical Corporation
Fountain Valley, California, United States
eStudySite
La Mesa, California, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Snake River Research
Idaho Falls, Idaho, United States
Anne Arundel Health System Research Institute
Annapolis, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Mercury St. Medical Group
Butte, Montana, United States
Quality Clinical Research
Omaha, Nebraska, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Remington Davis
Columbus, Ohio, United States
Regional Infectious Diseases & Infusion Center
Lima, Ohio, United States
Baylor Scott & White Research Institute
Temple, Texas, United States
Dr. Hansen Internal Medicine
Bountiful, Utah, United States
Infectious Disease Associates of Central Virginia
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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SER-262-001
Identifier Type: -
Identifier Source: org_study_id
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