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A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Clinical Food Study to Assess the Safety, Tolerability, and Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointesinal Tracts Are Colonized With Multiple Drug-resistant Organisms

Trial Profile

A Randomized, Open-Label, Prospective, Parallel Group, 2-Part Clinical Food Study to Assess the Safety, Tolerability, and Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointesinal Tracts Are Colonized With Multiple Drug-resistant Organisms

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs KB 109 (Primary)
  • Indications Bacterial infections; Enterobacteriaceae infections; Vancomycin-resistant enterococcal infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms VITORA
  • Sponsors Kaleido Biosciences
  • Most Recent Events

    • 20 Jan 2021 Status changed from recruiting to discontinued. Reason the study was stopped:COVID-19 pandemic.
    • 10 Mar 2020 Planned number of patients changed from 64 to 50.
    • 10 Mar 2020 Planned End Date changed from 1 Feb 2020 to 1 Nov 2020.

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