Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the
Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects
with Recurrence of Clostridium difficile Infection (CDI).

Inclusion Criteria:

- Ability to provide written informed consent

- Men or women 18 years of age or older

- Current diagnosis of a recurrence of non-severe, non-complicated CDI

- Subject has a clinical response to standard-of-care CDI antibiotics for the most
recent CDI episode

Exclusion Criteria:

- Pregnant, breast-feeding, or considering becoming pregnant during the study

- Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's
disease and ulcerative colitis)

- Any prior diagnosis of diarrhea-predominant irritable bowel syndrome

- Systemic chemotherapy or radiation for the treatment of cancer during the 60 days
prior to consent or planned during the 8 weeks following Randomization

- Prior fecal transplant for any condition, regardless of route of administration in the
last year or plans to undergo during the study

- Major intra-abdominal surgery within the past 60 days prior to Screening

- History of total colectomy/ileostomy or bariatric surgery

- Admitted to, or expected to be admitted to an intensive care unit for any medical
reason. Note: Residents of long term care facilities are eligible study entry

- Planned hospitalization or invasive surgery during the study

- Severe acute illness unrelated to CDI