deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT05201079

Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin

A Randomised, Controlled, Open-label Phase III Clinical Trial in Patients With Primary or Recurrent Clostridioides Difficile (CD) Infection, to Evaluate the Efficacy and Safety of Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin.

Sponsor: Mikrobiomik Healthcare Company S.L.

Updated 8 times since 2022 Last updated: Mar 7, 2025 Started: Oct 29, 2021 Primary completion: Nov 15, 2023 Completion: Nov 15, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Primary Clostridium Difficile Infection and Recurrent Clostridium Difficile Infection and is currently completed. Mikrobiomik Healthcare Company S.L. leads this study, which shows 8 recorded versions since 2021 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Feb 2022 – ~Jul 2022 · 5 months · monthly snapshotRecruiting~Jul 2022 – ~Dec 2022 · 5 months · monthly snapshotRecruiting~Dec 2022 – ~Feb 2024 · 14 months · monthly snapshotRecruiting~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshotCompleted~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Apr 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Apr 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: RecruitingCompleted

Show 3 earlier versions
  1. Dec 2022 — Feb 2024 [monthly]

    Recruiting PHASE3

  2. Jul 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  3. Feb 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

    First recorded

Oct 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mikrobiomik Healthcare Company S.L.
Data source: Mikrobiomik Healthcare Company S.L.

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