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

Phase 2

Completed

• Conditions: Fecal Microbiota; FMT; Fecal Transplant; C. Diff; Clostridium Difficile Infection; Recurrent Clostridium Difficile Infection; CDI; Recurrent C. Diff; rCDI; C. Difficile

• Registration Number: NCT03497806
• Lead Sponsor: Finch Research and Development LLC.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-13
• Study Start: 2018-05-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-01
• Results First Submitted: 2022-06-29
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Results First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

1. Pregnant, breast-feeding, or considering becoming pregnant during the study
2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
5. Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
6. Major intra-abdominal surgery within the past 60 days prior to Screening
7. 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
8. History of total colectomy/ileostomy or bariatric surgery
9. Planned hospitalization or invasive surgery during the study
10. Severe acute illness unrelated to CDI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication	Up to Week 8	Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Occurence of Treatment Emergent Adverse Events (TEAEs)	Week 8

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication	Up to Week 24	Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.

Trial Locations

Locations (54)

Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

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, District of Columbia, United States

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