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SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) (ECOSPOR)

This study has been completed.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02437487
First received: May 5, 2015
Last updated: November 16, 2016
Last verified: October 2016
  Purpose
The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

Condition Intervention Phase
Clostridium Difficile Drug: SER-109 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

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

Primary Outcome Measures:
  • Relative risk of recurrence of CDI up to 8 weeks after treatment. [ Time Frame: 8 weeks after treatment. ]

Secondary Outcome Measures:
  • Time to recurrence of CDI [ Time Frame: Recurrence of CDI up to 4, 8, 12 and 24 weeks after treatment. ]

Enrollment: 89
Study Start Date: May 2015
Study Completion Date: October 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SER-109
SER 109 (1 × 108 SporQs)
Drug: SER-109
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
Other Name: Purified Eubacterial Spores, Encapsulated
Placebo Comparator: Placebo
Placebo
Drug: 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.

Detailed Description:

ECOSPOR is a Phase 2, multicenter, randomized, double blind, placebo controlled clinical study with 2 treatment arms (SER-109 or placebo). Patients who have diarrhea and a positive C. difficile test result on a stool sample, and who have responded to standard of care antibiotic treatment will receive study drug on Day 1.

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).

  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 patient understands the purpose of and procedures required for the study. Patients who are unable to provide informed consent will not be included in the study.
  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:

  1. Female patients 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 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).
  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: NCT02437487

  Show 30 Study Locations
Sponsors and Collaborators
Seres Therapeutics, Inc.
INC Research
Investigators
Study Director: Michele Trucksis, Phd, MD Seres Therapeutics
  More Information

Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02437487     History of Changes
Other Study ID Numbers: SERES-004
Study First Received: May 5, 2015
Last Updated: November 16, 2016

ClinicalTrials.gov processed this record on June 23, 2017