deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT03497806

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

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

Sponsor: Finch Research and Development LLC.

Conditions C. Diff C. Difficile CDI Clostridium Difficile Infection FMT Fecal Microbiota Fecal Transplant Recurrent C. Diff Recurrent CDI Recurrent Clostridium Difficile Infection rCDI
Interventions CP101
Updated 17 times since 2018 Last updated: Aug 10, 2022 Started: May 1, 2018 Primary completion: Dec 31, 2020 Completion: Apr 1, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on C. Diff and C. Difficile, this trial is completed. The trial is conducted by Finch Research and Development LLC. and has accumulated 17 data snapshots since 2018. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Feb 2019 · 5 months · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~Sep 2019 · 5 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Feb 2020 · 4 months · monthly snapshot~Feb 2020 – ~Sep 2020 · 7 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Sep 2022 · 19 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

▶ Show 12 earlier versions

  1. Sep 2022 — Dec 2022 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Feb 2021 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  4. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

    Status: Enrolling By Invitation → Recruiting

  5. Feb 2020 — Sep 2020 [monthly]

    Enrolling By Invitation PHASE2

  6. Oct 2019 — Feb 2020 [monthly]

    Enrolling By Invitation PHASE2

  7. Sep 2019 — Oct 2019 [monthly]

    Enrolling By Invitation PHASE2

  8. Apr 2019 — Sep 2019 [monthly]

    Enrolling By Invitation PHASE2

  9. Feb 2019 — Apr 2019 [monthly]

    Enrolling By Invitation PHASE2

  10. Sep 2018 — Feb 2019 [monthly]

    Enrolling By Invitation PHASE2

    Status: Not Yet Recruiting → Enrolling By Invitation

  11. Jun 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE2

  12. May 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Finch Research and Development LLC.
  • Medpace, Inc.
Data source: Finch Research and Development LLC.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Annandale, United States , Atlanta, United States , Aurora, United States , Boston, United States , Bridgeport, United States , Burr Ridge, United States , Butte, United States , Calgary, Canada , Chapel Hill, United States , Charlottesville, United States and 44 more locations