deltatrials
Terminated PHASE4 INTERVENTIONAL 2-arm NCT01972932

Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea

Protocol CHUM 2014-5056: A Randomized, Double Blinded Placebo Controlled Study to Evaluate the Efficacy of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea in Hospitalized Patients

Sponsor: Bio-K Plus International Inc.

Conditions Antibiotic Associated Diarrhea Clostridium Difficile Infection
Interventions Bio K+® 2 capsules orally (or via nasogastric tube) Placebo
Updated 7 times since 2017 Last updated: Jul 21, 2022 Started: Nov 30, 2013 Primary completion: Nov 30, 2014 Completion: Aug 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Recruitment problems

This PHASE4 trial investigates Antibiotic Associated Diarrhea and Clostridium Difficile Infection and is currently terminated or withdrawn. Bio-K Plus International Inc. leads this study, which shows 7 recorded versions since 2013 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Jan 2017 – ~Sep 2017 · 8 months · monthly snapshotTerminated~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Sep 2022 · 20 months · monthly snapshotTerminated~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  3. Sep 2022 — Jul 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Sep 2022 [monthly]

    Terminated PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE4

▶ Show 2 earlier versions

  1. Sep 2017 — Jun 2018 [monthly]

    Terminated PHASE4

  2. Jan 2017 — Sep 2017 [monthly]

    Terminated PHASE4

    First recorded

Nov 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bio-K Plus International Inc.
  • Centre hospitalier de l'Université de Montréal (CHUM)
Data source: Bio-K Plus International Inc.

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

Study Locations