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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Seres Therapeutics, Inc.
Sponsor:
Collaborator:
Pharm-Olam International
Information provided by (Responsible Party):
Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02830542
First received: July 6, 2016
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Clostridium Difficile Infection Drug: SER-262 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability and Efficacy of SER-262 in Adults With Primary Clostridium Difficile Infection (CDI) to Prevent Recurrence

Further study details as provided by Seres Therapeutics, Inc.:

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

Estimated Enrollment: 60
Study Start Date: July 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SER-262
SER-262 [10(4), 10(5), 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
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.

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 5 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.
  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02830542

  Show 22 Study Locations
Sponsors and Collaborators
Seres Therapeutics, Inc.
Pharm-Olam International
Investigators
Study Director: Michele Trucksis, PhD, MD Seres Therapeutics
  More Information

Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02830542     History of Changes
Other Study ID Numbers: SER-262-001
Study First Received: July 6, 2016
Last Updated: January 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Seres Therapeutics, Inc.:
Clostridium difficile
C Diff
CDI

Additional relevant MeSH terms:
Infection
Communicable Diseases
Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 16, 2017