This trial is active, not recruiting.

Condition clostridium difficile
Treatments ser-109, placebo
Phase phase 2
Sponsor Seres Therapeutics, Inc.
Collaborator INC Research
Start date May 2015
End date June 2016
Trial size 87 participants
Trial identifier NCT02437487, SERES-004


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
SER 109 (1 × 108 SporQs)
ser-109 Purified Eubacterial Spores, Encapsulated
SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
(Placebo Comparator)
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.

Primary Outcomes

Relative risk of recurrence of CDI up to 8 weeks after treatment.
time frame: 8 weeks after treatment.

Secondary Outcomes

Time to recurrence of CDI
time frame: Recurrence of CDI up to 4, 8, 12 and 24 weeks after treatment.

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title ECOSPOR: A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Seres Therapeutics, Inc..