Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (PRISM3)

Finch Therapeutics

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile Infection Recurrence

Treatments: Drug: Full Spectrum Microbiota; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03110133

CDI-001

Details and patient eligibility

About

Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile.

Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.

Full description

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).

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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206 participants in 2 patient groups, including a placebo group

CP101

Experimental group

Description:

Full Spectrum Microbiota Capsule

Treatment:

Drug: Full Spectrum Microbiota

Placebo

Placebo Comparator group

Description:

Matching Placebo Capsule

Treatment:

Drug: Placebo