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

  • STATUS
    Recruiting
  • End date
    Apr 4, 2021
  • participants needed
    70
  • sponsor
    Finch Research and Development LLC.
Updated on 10 August 2020
Investigator
Shrish Budree, MD
Primary Contact
Washington DC (4.5 mi away) Contact
+47 other location
antibiotic therapy
antibiotics
microbiota
clostridium difficile

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.

Details
Treatment CP101
Clinical Study IdentifierNCT03497806
SponsorFinch Research and Development LLC.
Last Modified on10 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Recurrent CDI or C. Diff or Fecal Transplant or Clostridium Difficile Infection or rCDI or C. Difficile or Compact Disk Interactive or Recurrent Clost...?
Ability to provide written informed consent
Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI
An outpatient prior to Treatment
Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period

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
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
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