ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: SER-109; Placebo
Intervention description: SER-109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Other Names:
Eubacterial Spores, Purified Suspension, Encapsulated; 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(0.9%).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days
      in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group
      II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to
      reduce recurrence of CDI as determined by a toxin assay in adults up to 8 weeks after
      initiation of treatment.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Signed informed consent prior to initiation of any study-specific procedure or
             treatment. The subject or their legally authorized representative must be able to
             provide written informed consent and understand the potential risks and benefits from
             study enrollment and treatment.

          2. Male or female subject ≥ 18 years of age.

          3. A qualifying episode of CDI as defined by:

               1. ≥ 3 unformed stools per day for 2 consecutive days

               2. A positive C. difficile stool toxin assay.

               3. The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of
                  treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]).

               4. An adequate clinical response following SOC antibiotic therapy, defined as (<3
                  unformed stools in 24 hours) for 2 or more consecutive days before randomization.

        Main Exclusion Criteria:

          1. Female subjects 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. Admitted to or expected to be admitted to an intensive care unit for medical reasons
             (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and
             acute care hospitals are acceptable.

          4. Absolute neutrophil count of <500 cells/ml^3

          5. Major gastrointestinal surgery (e.g. 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 (bariatric surgery which does not
             disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are
             permitted).

          6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease,
             microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel
             disease in the past 3 months.

          7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for
             active malignancy (subjects on maintenance chemotherapy may only be enrolled after
             consultation with the study medical monitor).

          8. Any history of fecal microbiota transplantation (FMT) within the previous 3 months.