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

Completed · Phase 2 · Has a placebo group

Conditions studied: Clostridium Difficile Infection Recurrence

In brief

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.

Key facts

Study ID

NCT03110133

Run by

Finch Research and Development LLC.

People needed

206

Starts

2017-05-08

Expected to finish

2020-06-18

Last updated by the study team

2022-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles — Los Angeles, California, United States
• Murrieta — Murrieta, California, United States
• Oakland — Oakland, California, United States
• San Diego — San Diego, California, United States
• San Francisco — San Francisco, California, United States
• Aurora — Aurora, Colorado, United States
• Bridgeport — Bridgeport, Connecticut, United States
• Hamden — Hamden, Connecticut, United States
• Washington DC — Washington D.C., District of Columbia, United States
• Jacksonville — Jacksonville, Florida, United States
• Naples — Naples, Florida, United States
• Pinellas Park — Pinellas Park, Florida, United States
• Tampa — Tampa, Florida, United States
• Atlanta — Atlanta, Georgia, United States
• Idaho Falls — Idaho Falls, Idaho, United States
• Burr Ridge — Burr Ridge, Illinois, United States
• Chicago — Chicago, Illinois, United States
• Evanston — Evanston, Illinois, United States
• Maywood — Maywood, Illinois, United States
• Indianapolis — Indianapolis, Indiana, United States
• West Des Moines — West Des Moines, Iowa, United States
• Shawnee — Shawnee Mission, Kansas, United States
• New Orleans — New Orleans, Louisiana, United States
• Boston — Boston, Massachusetts, United States
• Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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