ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
Condition: Clostridioides Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: SER-109
Intervention description: SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridioides infection; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Communicable Diseases

Summary:

      Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study
      SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this
      cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults
      who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study
      SERES-012.

      Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The
      purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years
      of age or older with at least a first recurrence of CDI.
    

Eligibility criteria:

        Cohort 1 Main Inclusion Criteria:

          1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after
             receipt of a treatment regimen of SER-109 or placebo

          2. 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.

          3. The CDI recurrence in Study SERES-012 must have met the protocol definition of ≥ 3
             unformed stools per day over 2 consecutive days, a positive C. difficile stool toxin
             assay, and the requirement of CDI SOC antibiotic therapy, and an adequate clinical
             response following antibiotic therapy (<3 unformed stools in 24 hours for 2 or more
             consecutive days).

        Cohort 1 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/mm^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) in the past 3 months.

        Cohort 2 Main Inclusion Criteria:

          1. Subjects 18 years of age or older who had one or more CDI recurrence (as confirmed by
             a C. difficile stool toxin or PCR test) and have responded to a course of antibiotic
             treatment.

          2. 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.

        Cohort 2 Main Exclusion Criteria:

        (all Cohort 1 exclusion criteria [#1-8 above] plus the below addition criterion)

        9. Previously enrolled in a Seres Therapeutics clinical study. An exception is made for
        subjects who screened in SERES-012 who did not receive SER-109 and did not previously
        roll-over to SERES-013.