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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02830542
Recruitment Status : Unknown
Verified March 2018 by Seres Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : April 20, 2018
Pharm-Olam International
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: SER-262 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: 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]
Drug: 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.
Other Name: Cultivated Eubacterial Spore Suspension, Encapsulated

Placebo Comparator: Placebo
Drug: 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.

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Time to recurrence of CDI [ Time Frame: Up to 24 weeks after treatment ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02830542

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Sponsors and Collaborators
Seres Therapeutics, Inc.
Pharm-Olam International
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Study Director: Michele Trucksis, PhD, MD Seres Therapeutics
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Responsible Party: Seres Therapeutics, Inc. Identifier: NCT02830542    
Other Study ID Numbers: SER-262-001
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Seres Therapeutics, Inc.:
Clostridium difficile
C Diff
Additional relevant MeSH terms:
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Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases