Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Completed · Phase 2

Conditions studied: Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff, CDI, Recurrent C. Diff, rCDI, C. Difficile, Recurrent CDI, FMT, Fecal Microbiota, Fecal Transplant

In brief

This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101. Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.

Key facts

Study ID

NCT03497806

Run by

Finch Research and Development LLC.

People needed

132

Starts

2018-05-01

Expected to finish

2021-04-01

Last updated by the study team

2022-08-30

Who can join

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

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
• 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
• History of total colectomy/ileostomy or bariatric surgery
• 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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